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Panels › Anesthesiology › Product code BTM · Class 2

Ventilator, Emergency, Manual (Resuscitator)

Regulation 868.5915

2510(k)s in 12 months (210 all time)
1recalls in 12 months (97 all time)
80recalls that name a 510(k)
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Top companies in BTM

DateFirm and productCodeLinked 510(k)
Jun 18, 2026Datex-Ohmeda Inc
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-
Open, Classified
BTMK070247
Aug 13, 2025Ambu Inc.
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Re
Open, Classified
BTMK152931
May 30, 2025SunMed Holdings, LLC
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Open, Classified
BTMK953546
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
Open, Classified
BTMNone listed
Feb 25, 2024Vyaire Medical
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
Open, Classified
BTMNone listed
Nov 21, 2023SunMed Holdings, LLC
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care In
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscita
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F;
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF
Open, Classified
BTMK012842
Aug 8, 2018Vyaire Medical
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen r
Terminated
BTMNone listed
Aug 8, 2018Vyaire Medical
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve,
Terminated
BTMNone listed
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
Terminated
BTMK953546
May 24, 2018Sun Med, LLC
STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
Terminated
BTMK953546
Jun 24, 2015Teleflex Medical
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended
Terminated
BTMK964719
Jul 3, 2014Ventlab LLC
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC81
Terminated
BTMK012842
K953546 +1
Feb 25, 2014GE Healthcare, LLC
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipme
Terminated
BTMK070247
Feb 3, 2014GE Healthcare
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equip
Terminated
BTMK070247
Feb 3, 2014GE Healthcare
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required
Terminated
BTMK070247
Aug 13, 2013Carefusion 2200 Inc
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, V
Terminated
BTMK924610
Feb 8, 2013GE Healthcare, LLC
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment
Terminated
BTMK070247
Nov 1, 2012Ventlab Corporation
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monito
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
Terminated
BTMK012842
Nov 1, 2012Ventlab Corporation
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence o
Terminated
BTMK012842

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