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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)
Sep 18, 2026CooperSurgical, 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
BZDK911780
Sep 18, 2026CooperSurgical, 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
BZDK911780
Jul 15, 20263B 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
BZDK112271
Aug 8, 2025Philips Respironics, Inc.
DreamStation Auto. Non-Continuous Ventilator.
Open, Classified
BZDK131982
Aug 8, 2025Philips Respironics, Inc.
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Open, Classified
BZDK131982
Aug 8, 2025Philips Respironics, Inc.
DreamStation Auto CPAP. Non-Continuous Ventilator.
Open, Classified
BZDK131982
Apr 1, 2024SleepNet Corporation
Phantom 2 Nasal Vented Mask
Open, Classified
BZDK211274
Apr 1, 2024SleepNet Corporation
iQ 2 Nasal Vented Mask
Open, Classified
BZDK211274
Apr 1, 2024SleepNet Corporation
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Open, Classified
BZDK190533
Apr 1, 2024SleepNet Corporation
Mojo 2 Full Face Non Vented Mask, All Sizes
Open, Classified
BZDK190533
Apr 1, 2024SleepNet Corporation
Mojo 2 Full Face Vented Mask, All Sizes
Open, Classified
BZDK190254
Apr 1, 2024SleepNet Corporation
Mojo Non Vented Full Face Mask with Headgear, All Sizes
Open, Classified
BZDK063806
Apr 1, 2024SleepNet Corporation
Mojo Full Face with Headgear, All Sizes
Open, Classified
BZDK120463
Dec 21, 2023ResMed Ltd.
AirFit F30i Full Face Mask and User Guide
Open, Classified
BZDK183512
Dec 21, 2023ResMed Ltd.
AirFit F30 Full Face Mask and User Guide
Open, Classified
BZDK170924
Dec 21, 2023ResMed Ltd.
AirTouch N20 Nasal Mask and User Guide
Open, Classified
BZDK161978
Dec 21, 2023ResMed Ltd.
AirFit N20 Nasal Mask and User Guide
Open, Classified
BZDK171212
Dec 21, 2023ResMed Ltd.
AirTouch F20 Full Face Mask and User Guide
Open, Classified
BZDK153563
Dec 21, 2023ResMed Ltd.
AirFit F20 Full Face Mask and User Guide
Open, Classified
BZDK170924
Dec 21, 2023ResMed Ltd.
AirFit N10 Nasal Masks and User Guide
Open, Classified
BZDK132887
May 17, 2023Draeger Medical, Inc.
Seattle PAP Plus, MP02260
Terminated
BZDK131502
Apr 6, 2023Philips 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
BZDK131982
Sep 30, 2022Philips Respironics, Inc.
Therapy Mask 3100 NC/SP
Open, Classified
BZDK210386
Sep 30, 2022Philips Respironics, Inc.
Wisp and Wisp Youth Nasal Mask
Open, Classified
BZDK121631
K140268
Sep 30, 2022Philips Respironics, Inc.
DreamWisp Nasal Mask with Over the Nose Cushion
Open, Classified
BZDK140980
Sep 30, 2022Philips Respironics, Inc.
Philips Respironics DreamWear Full Face Mask
Open, Classified
BZDK142554
Sep 30, 2022Philips Respironics, Inc.
Philips Respironics Amara View Minimal Contact Full-Face Mask
Open, Classified
BZDK082866
Jul 13, 2021Philips 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
BZDK091319
K113068 +4
Dec 20, 2019Galemed 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
BZDK110383
Dec 20, 2019Galemed Corporation
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Terminated
BZDK110383
Dec 20, 2019Galemed Corporation
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Terminated
BZDK110383
Nov 7, 2019TELEFLEX-MORRISVILLE
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Terminated
BZDK110383
Aug 20, 2018Compass 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
BZDK063268
Jul 12, 2016Resmed Corporation
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Terminated
BZDK123979
Dec 2, 2014Beevers 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
BZDNone listed
Dec 1, 2014Beevers 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
BZDNone listed
Jul 1, 2014DeVilbiss 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
BZDK071689
K091919 +1
May 30, 2013Fisher & 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
BZDK094040
Aug 10, 2011Sunrise 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
BZDK071689
Jun 17, 2009Respironics
Remstar Pro M-Series Heated Humidifier System.
Terminated
BZDK072996
May 14, 2008Cardinal 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
BZDK051226
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK041010
K052110
Apr 24, 2008Respironics, 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
BZDK000994
Apr 24, 2008Respironics, 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
BZDK954207
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK011714
K052110
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK052110
Apr 24, 2008Respironics, 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
BZDK954207

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