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)
Top companies in BTM
| Company | 510(k)s | Recalls |
|---|---|---|
| Unomedical | 0 | 23 |
| Ventlab Corp. | 2 | 19 |
| Ambu, Inc. | 15 | 1 |
| Sun Med, LLC | 0 | 14 |
| Puritan Bennett Corp. | 13 | 0 |
| Medical Marketing Concepts | 11 | 0 |
| Vyaire Medical | 0 | 11 |
| SunMed Holdings, LLC | 0 | 10 |
| Laerdal Medical AS | 3 | 4 |
| Life Design Systems, Inc. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Datex-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 |
BTM | K070247 |
| Aug 13, 2025 | Ambu 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 |
BTM | K152931 |
| May 30, 2025 | SunMed Holdings, LLC Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F Open, Classified |
BTM | K953546 |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, Open, Classified |
BTM | None listed |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Aug 8, 2018 | Vyaire 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 |
BTM | None listed |
| Aug 8, 2018 | Vyaire 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 |
BTM | None listed |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126 Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5 Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116 Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 Terminated |
BTM | K953546 |
| Jun 24, 2015 | Teleflex 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 |
BTM | K964719 |
| Jul 3, 2014 | Ventlab 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 |
BTM | K012842 K953546 +1 |
| Feb 25, 2014 | GE 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 |
BTM | K070247 |
| Feb 3, 2014 | GE 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 |
BTM | K070247 |
| Feb 3, 2014 | GE 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 |
BTM | K070247 |
| Aug 13, 2013 | Carefusion 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 |
BTM | K924610 |
| Feb 8, 2013 | GE 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 |
BTM | K070247 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
| Nov 1, 2012 | Ventlab Corporation Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. Terminated |
BTM | K012842 |
| Nov 1, 2012 | Ventlab 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 |
BTM | K012842 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.