Company ยท US
Respironics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.
174510(k) clearances (1 in 12 months)
54recalls (0 in 12 months)
51recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 93 |
| CBK | Ventilator, Continuous, Facility Use | 28 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 14 |
| MNR | Ventilatory Effort Recorder | 8 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 7 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 6 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 5 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 5 |
| CAW | Generator, Oxygen, Portable | 5 |
| NPF | Monitor, Apnea, Home Use | 4 |
| BYJ | Unit, Liquid-Oxygen, Portable | 3 |
| CBH | Device, Fixation, Tracheal Tube | 3 |
| GWK | Conditioner, Signal, Physiological | 3 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 3 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 2 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 |
| BZQ | Monitor, Breathing Frequency | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 |
| FLS | Monitor, Apnea, Facility Use | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2026 | K261262 | Altis Full Face Mask Respironics, Inc. | BZD |
| Dec 30, 2024 | K243394 | AF531 Oro-Nasal SE Face Mask Respironics, Inc. | CBK |
| Jul 28, 2023 | K231313 | Therapy Mask 3100 NC/SP Respironics, Inc. | BZD |
| Aug 24, 2021 | K210844 | DreamWear Silicone Pillows Mask Respironics, Inc. | BZD |
| Jul 12, 2021 | K210386 | Magneto Nasal Mask Respironics, Inc. | BZD |
| Oct 29, 2020 | K202142 | Sleepware G3 Respironics, Inc. | OLZ |
| Sep 25, 2020 | K201439 | Ventilator, Non-continuous (Respirator) Respironics, Inc. | BZD |
| Jul 10, 2020 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System Respironics, Inc. | BZD |
| Oct 18, 2019 | K183625 | SomnaPatch Respironics, Inc. | MNR |
| Oct 18, 2019 | K183226 | Care Orchestrator Essence Respironics, Inc. | BZD |
| Jul 18, 2019 | K181170 | Trilogy Evo Universal Respironics, Inc. | CBK |
| Jul 18, 2019 | K181166 | Trilogy Evo Respironics, Inc. | CBK |
| Jan 4, 2019 | K181053 | Care Orchestrator Respironics, Inc. | BZD |
| Feb 17, 2017 | K161411 | Care Cycle Connect Application Respironics, Inc. | MOD |
| Apr 15, 2016 | K151120 | Simple T Pediatric Nasal Mask Respironics, Inc. | BZD |
| Jan 8, 2016 | K152356 | Sapphire Respironics, Inc. | BZD |
| Sep 18, 2015 | K150639 | AF541 EE Full Face Mask Respironics, Inc. | BZD |
| Sep 18, 2015 | K150638 | AF541 SE Full Face Mask Respironics, Inc. | CBK |
| Mar 16, 2015 | K142988 | Sleepware G3 Respironics, Inc. | OLZ |
| Feb 10, 2015 | K140980 | TI NASAL MASK Respironics, Inc. | BZD |
| Jan 9, 2015 | K142554 | Revolution Full Face Mask Respironics, Inc. | BZD |
| Nov 14, 2014 | K140424 | RESPIRONICS REUSABLE HEATED TUBING Respironics, Inc. | BZE |
| Oct 20, 2014 | K140268 | SIMPLE T YOUTH NASAL MASK Respironics, Inc. | BZD |
| Nov 20, 2013 | K132168 | BRONCHOSCOPY ELBOW Respironics, Inc. | BZD |
| Oct 18, 2013 | K131982 | REMSTAR AUTO A-FLEX HT Respironics, Inc. | BZD |
| Oct 17, 2013 | K131994 | SOMNOLYZER 24X7 Respironics, Inc. | MNR |
| May 21, 2013 | K130077 | REMSTAR SE Respironics, Inc. | BZD |
| Mar 6, 2013 | K122847 | KANGAROO NASAL MASK Respironics, Inc. | BZD |
| Dec 31, 2012 | K122111 | RESPIRONICS SIMPLYCLEAR DEVICE Respironics, Inc. | SDT |
| Dec 14, 2012 | K121955 | COUGHASSIST T70 DEVICE Respironics, Inc. | NHJ |
| Dec 14, 2012 | K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM Respironics, Inc. | MNT |
| Oct 9, 2012 | K122769 | REMSTAR SE Respironics, Inc. | BZD |
| Oct 5, 2012 | K121631 | SIMPLE T NASAL MASK Respironics, Inc. | BZD |
| Jul 17, 2012 | K120562 | PERFORMAX PEDIATRIC EE TOTAL FACE MASK Respironics, Inc. | BZD |
| Jul 10, 2012 | K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK Respironics, Inc. | CBK |
| Mar 30, 2012 | K120145 | SIMPLE T NASAL MASK Respironics, Inc. | BZD |
| Feb 1, 2012 | K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM Respironics, Inc. | MNS |
| Dec 16, 2011 | K113068 | REMSTAR AUTO A-FLEX HT Respironics, Inc. | BZD |
| Nov 4, 2011 | K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR Respironics, Inc. | CAW |
| Oct 14, 2011 | K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY Respironics, Inc. | CBK |
| Jun 6, 2011 | K110405 | TRUBLUE NASAL MASK Respironics, Inc. | BZD |
| Jun 1, 2011 | K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS Respironics, Inc. | BZE |
| Apr 5, 2011 | K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics, Inc. | MNT |
| Mar 24, 2011 | K103395 | PERFORMAX TOTAL FACE MASK Respironics, Inc. | BZD |
| Mar 24, 2011 | K102465 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM Respironics, Inc. | MNS |
| Feb 17, 2011 | K110008 | GOLIFE NASAL MASK Respironics, Inc. | BZD |
| Dec 22, 2010 | K102502 | GOLIFE NASAL MASK Respironics, Inc. | BZD |
| Sep 16, 2010 | K101129 | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK Respironics, Inc. | CBK |
| Sep 2, 2010 | K101130 | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK Respironics, Inc. | MNS |
| May 12, 2010 | K093905 | TRILOGY 202 VENTILATOR Respironics, Inc. | CBK |
Newest 50 of 174.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2012 | Respironics, Inc. Respironics Trilogy 100, 200, and 202 Ventilators
The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilatio Terminated |
CBK | K083526 K093416 +1 |
| Jan 11, 2012 | Respironics, Inc. Trilogy 100, 200 and 202 Ventilators
The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and Terminated |
CBK | K083526 |
| Jun 24, 2010 | Respironics, Inc. Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146.
Provides continuous or intermittent ventilatory support for the care of individ Terminated |
CBK | K083526 |
| Jun 17, 2009 | Respironics Remstar Pro M-Series Heated Humidifier System. Terminated |
BZD | K072996 |
| May 19, 2009 | Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor.
The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor det Terminated |
FLS | K011597 |
| Sep 18, 2008 | Respironics, Inc. Power Board Kit for use with the PLV-100 Portable Lifecare repairs Terminated |
CBK | K832467 |
| Sep 18, 2008 | Respironics, Inc. PLV-100 Portable Lifecare Ventilator Life support ventilation
The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breat Terminated |
CBK | K832467 |
| Apr 24, 2008 | Respironics, Inc. Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
FLS | K011597 |
| Apr 24, 2008 | Respironics, Inc. Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
DOA | K002690 |
| Apr 24, 2008 | Respironics, Inc. Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
NPF | K032403 |
| Apr 24, 2008 | Respironics, Inc. ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
GWO | K922106 |
| Apr 24, 2008 | Respironics, Inc. Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNR | K052573 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/CAN model number 1010771; b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771; c) Synchrony S w/o mod Terminated |
MNS | K020777 K071509 |
| Apr 24, 2008 | Respironics, Inc. Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNR | K052573 |
| Apr 24, 2008 | Respironics, Inc. APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Sma Terminated |
NPF | K061256 |
| Apr 24, 2008 | Respironics, Inc. Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model n Terminated |
CBK | K842876 K982454 |
| Apr 24, 2008 | Respironics, Inc. RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N. AMER model number 362524. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironic Terminated |
BZD | K041010 K052110 |
| Apr 24, 2008 | Respironics, Inc. RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K000994 |
| Apr 24, 2008 | Respironics, Inc. RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cu Terminated |
BZD | K954207 |
| Apr 24, 2008 | Respironics, Inc. RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /P Terminated |
BZD | K011714 K052110 |
| Apr 24, 2008 | Respironics, Inc. RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S ComfortGel Cush and Flap model number 1031392. Filter, mask, Terminated |
BZD | K954207 |
| Apr 24, 2008 | Respironics, Inc. RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel Cush and Flap model number 1031404 and b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, Terminated |
BZD | K954207 |
| Apr 24, 2008 | Respironics, Inc. Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/ Terminated |
BZD | K021861 K052110 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model n Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar M US model number DS100 and b) REMStar M w/Humid US model number DS100H. Filter, mask, and/or accessories for sleep Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K010263 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REM Terminated |
BZD | K041010 K052110 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilators accessories under the following brand names: a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS and b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA51 Terminated |
BZD | K041010 K052110 |
| Apr 24, 2008 | Respironics, Inc. Power Cord Accessory under the following brand names a) Power Cord W/C7 End Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model number 1005894. Filter, mask, and/or accessories Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNS | K020777 K071509 |
| Apr 24, 2008 | Respironics, Inc. Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | K842876 |
| Apr 24, 2008 | Respironics, Inc. M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K052110 |
| Apr 24, 2008 | Respironics, Inc. Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNT | K842876 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Terminated |
GWQ | K040595 K982454 |
| Apr 24, 2008 | Respironics, Inc. Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193; Terminated |
BZD | K052110 K842876 +1 |
| Apr 24, 2008 | Respironics, Inc. BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | K050759 |
| Jan 10, 2007 | Respironics, Inc. REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265 Terminated |
BTT | K010263 |
| Jan 10, 2007 | Respironics, Inc. REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. Terminated |
BTT | K010263 |
| Jul 1, 2006 | Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 Terminated |
CBK | K040862 |
| Apr 7, 2006 | Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System
(Ventilator, Continuous) Terminated |
CBK | K040862 |
Newest 50 of 54.