ClearanceBrief
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)
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Top companies in BZD

DateFirm and productCodeLinked 510(k)
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK954207
Apr 24, 2008Respironics, 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
BZDK021861
K052110
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK010263
Apr 24, 2008Respironics, 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
BZDK041010
K052110
Apr 24, 2008Respironics, 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
BZDK041010
K052110
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK052110
K842876 +1
Apr 24, 2008Respironics, 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
BZDK050759
Jul 12, 2007Cardinal 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
BZDK051226
Jul 3, 2007Resmed 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
BZDK033841
K041209
Jun 27, 2007Fisher & 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
BZDK003894
K033087 +1
Jun 27, 2007Fisher & Paykel Healthcare Inc
Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks.
Terminated
BZDK003894
K033087 +1
Jun 27, 2007Fisher & Paykel Healthcare Inc
Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks.
Terminated
BZDK003894
K033087 +1
Jun 27, 2007Fisher & Paykel Healthcare Inc
Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks.
Terminated
BZDK003894
K033087 +1
Jun 27, 2007Fisher & Paykel Healthcare Inc
Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks.
Terminated
BZDK003894
K033087 +1
Jun 27, 2007Fisher & Paykel Healthcare Inc
Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks.
Terminated
BZDK003894
K033087 +1
Jun 7, 2007Teleflex 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
BZDK871157
Jun 7, 2007Teleflex 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
BZDK871157
Jun 7, 2007Teleflex 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
BZDK871157
Jun 7, 2007Teleflex 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
BZDK871157
Jun 7, 2007Teleflex 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
BZDK871157
Aug 3, 2005Chad Therapeutics Inc
Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
Terminated
BZDK000890
K003455
Dec 17, 2004Medical 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
BZDK002763
Dec 10, 2003Respironics, Inc.
ComfortGel Nasal Mask size large
Terminated
BZDNone listed
Dec 10, 2003Respironics, Inc.
ComfortGel Nasal Mask size medium
Terminated
BZDNone listed
Dec 10, 2003Respironics, Inc.
ComfortGel Nasal Mask size small
Terminated
BZDK954207
Oct 24, 2003Western a Scott Fetzer Co
Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.
Terminated
BZDK010747
Oct 24, 2003Western a Scott Fetzer Co
Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.
Terminated
BZDK010747
Oct 24, 2003Western 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
BZDK010747

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