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) |
|---|---|---|---|
| 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. 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. 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. 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 |
| Jul 12, 2007 | Cardinal Health AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or Terminated |
BZD | K051226 |
| Jul 3, 2007 | Resmed Corporation ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #3300 Terminated |
BZD | K033841 K041209 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask n Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 27, 2007 | Fisher & Paykel Healthcare Inc Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks. Terminated |
BZD | K003894 K033087 +1 |
| Jun 7, 2007 | Teleflex Medical Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Terminated |
BZD | K871157 |
| Jun 7, 2007 | Teleflex Medical Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Terminated |
BZD | K871157 |
| Jun 7, 2007 | Teleflex Medical Infant Nasal CPAP Cannula, Size 2; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Terminated |
BZD | K871157 |
| Jun 7, 2007 | Teleflex Medical Infant Nasal CPAP Cannula, Size 1; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Terminated |
BZD | K871157 |
| Jun 7, 2007 | Teleflex Medical Infant Nasal CPAP Cannula, Size 0; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Terminated |
BZD | K871157 |
| Aug 3, 2005 | Chad Therapeutics Inc Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***. Terminated |
BZD | K000890 K003455 |
| Dec 17, 2004 | Medical Industries America Inc RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA. Terminated |
BZD | K002763 |
| Dec 10, 2003 | Respironics, Inc. ComfortGel Nasal Mask size large Terminated |
BZD | None listed |
| Dec 10, 2003 | Respironics, Inc. ComfortGel Nasal Mask size medium Terminated |
BZD | None listed |
| Dec 10, 2003 | Respironics, Inc. ComfortGel Nasal Mask size small Terminated |
BZD | K954207 |
| Oct 24, 2003 | Western a Scott Fetzer Co Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label. Terminated |
BZD | K010747 |
| Oct 24, 2003 | Western a Scott Fetzer Co Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label. Terminated |
BZD | K010747 |
| Oct 24, 2003 | Western a Scott Fetzer Co Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label. Terminated |
BZD | K010747 |
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