Panels › Anesthesiology › Product code BZD · Class 2
Ventilator, Non-Continuous (Respirator)
Regulation 868.5905
12510(k)s in 12 months (463 all time)
3recalls in 12 months (83 all time)
79recalls that name a 510(k)
Top companies in BZD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | CooperSurgical, Inc. INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715. Open, Classified |
BZD | K911780 |
| Sep 18, 2026 | CooperSurgical, Inc. INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715. Open, Classified |
BZD | K911780 |
| Jul 15, 2026 | 3B Medical, Inc. Brand Name: Rio" II
Product Name: Rio" II Nasal Pillows Interface
Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)
Software Version: N/A
Product Description: Nasal pillows inte Open, Classified |
BZD | K112271 |
| Aug 8, 2025 | Philips Respironics, Inc. DreamStation Auto. Non-Continuous Ventilator. Open, Classified |
BZD | K131982 |
| Aug 8, 2025 | Philips Respironics, Inc. DreamStation Auto BiPAP. Non-Continuous Ventilator. Open, Classified |
BZD | K131982 |
| Aug 8, 2025 | Philips Respironics, Inc. DreamStation Auto CPAP. Non-Continuous Ventilator. Open, Classified |
BZD | K131982 |
| Apr 1, 2024 | SleepNet Corporation Phantom 2 Nasal Vented Mask Open, Classified |
BZD | K211274 |
| Apr 1, 2024 | SleepNet Corporation iQ 2 Nasal Vented Mask Open, Classified |
BZD | K211274 |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face AAV Non Vented Mask, All Sizes Open, Classified |
BZD | K190533 |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face Non Vented Mask, All Sizes Open, Classified |
BZD | K190533 |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face Vented Mask, All Sizes Open, Classified |
BZD | K190254 |
| Apr 1, 2024 | SleepNet Corporation Mojo Non Vented Full Face Mask with Headgear, All Sizes Open, Classified |
BZD | K063806 |
| Apr 1, 2024 | SleepNet Corporation Mojo Full Face with Headgear, All Sizes Open, Classified |
BZD | K120463 |
| Dec 21, 2023 | ResMed Ltd. AirFit F30i Full Face Mask and User Guide Open, Classified |
BZD | K183512 |
| Dec 21, 2023 | ResMed Ltd. AirFit F30 Full Face Mask and User Guide Open, Classified |
BZD | K170924 |
| Dec 21, 2023 | ResMed Ltd. AirTouch N20 Nasal Mask and User Guide Open, Classified |
BZD | K161978 |
| Dec 21, 2023 | ResMed Ltd. AirFit N20 Nasal Mask and User Guide Open, Classified |
BZD | K171212 |
| Dec 21, 2023 | ResMed Ltd. AirTouch F20 Full Face Mask and User Guide Open, Classified |
BZD | K153563 |
| Dec 21, 2023 | ResMed Ltd. AirFit F20 Full Face Mask and User Guide Open, Classified |
BZD | K170924 |
| Dec 21, 2023 | ResMed Ltd. AirFit N10 Nasal Masks and User Guide Open, Classified |
BZD | K132887 |
| May 17, 2023 | Draeger Medical, Inc. Seattle PAP Plus, MP02260 Terminated |
BZD | K131502 |
| Apr 6, 2023 | Philips Respironics, Inc. Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment o Open, Classified |
BZD | K131982 |
| Sep 30, 2022 | Philips Respironics, Inc. Therapy Mask 3100 NC/SP Open, Classified |
BZD | K210386 |
| Sep 30, 2022 | Philips Respironics, Inc. Wisp and Wisp Youth Nasal Mask Open, Classified |
BZD | K121631 K140268 |
| Sep 30, 2022 | Philips Respironics, Inc. DreamWisp Nasal Mask with Over the Nose Cushion Open, Classified |
BZD | K140980 |
| Sep 30, 2022 | Philips Respironics, Inc. Philips Respironics DreamWear Full Face Mask Open, Classified |
BZD | K142554 |
| Sep 30, 2022 | Philips Respironics, Inc. Philips Respironics Amara View Minimal Contact Full-Face Mask Open, Classified |
BZD | K082866 |
| Jul 13, 2021 | Philips Respironics, Inc. SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators
The Philips Respironics E30 ventilator is intended to provide invasive and non-in Open, Classified |
BZD | K091319 K113068 +4 |
| Dec 20, 2019 | Galemed Corporation Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802 Terminated |
BZD | K110383 |
| Dec 20, 2019 | Galemed Corporation Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559 Terminated |
BZD | K110383 |
| Dec 20, 2019 | Galemed Corporation Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 Terminated |
BZD | K110383 |
| Nov 7, 2019 | TELEFLEX-MORRISVILLE Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. Terminated |
BZD | K110383 |
| Aug 20, 2018 | Compass Health Brands (Corporate Office) CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L
Product Usage:
A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The rep Terminated |
BZD | K063268 |
| Jul 12, 2016 | Resmed Corporation Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators Terminated |
BZD | K123979 |
| Dec 2, 2014 | Beevers Manufacturing & Supply, Inc. Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help s Terminated |
BZD | None listed |
| Dec 1, 2014 | Beevers Manufacturing & Supply, Inc. Cannulaide, Model 101, 102, 103. Respirator.
The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a Terminated |
BZD | None listed |
| Jul 1, 2014 | DeVilbiss Healthcare LLC DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. Terminated |
BZD | K071689 K091919 +1 |
| May 30, 2013 | Fisher & Paykel Healthcare, Ltd. Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure).
Models:
ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ.
ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ.
ICON Premo: ICONPBN, ICONPB Terminated |
BZD | K094040 |
| Aug 10, 2011 | Sunrise Medical HHG Inc. dba DeVilbiss Healthcare DeVilbiss Model DV5x Series CPAP with Heated Humidifier
Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the p Terminated |
BZD | K071689 |
| Jun 17, 2009 | Respironics Remstar Pro M-Series Heated Humidifier System. Terminated |
BZD | K072996 |
| May 14, 2008 | Cardinal Health AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation dev Terminated |
BZD | K051226 |
| 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 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. 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. 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 |
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