510(k) K012842 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
V*CARE MANUAL RESUSCITATOR
| Applicant | Ventlab Corp., Mocksville NC, US |
| Decision | Substantially Equivalent, Sep 18, 2001 |
| Received | Aug 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
| 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 | None listed |
| Nov 1, 2012 | Ventlab Corporation Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
The Disposable Resuscitators with optional built-in pres Terminated |
BTM | None listed |
| Nov 1, 2012 | Ventlab Corporation Adult Resuscitator, Pro-5000 Series, Single Patient Use,
The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversibl Terminated |
BTM | None listed |
| Nov 1, 2012 | Ventlab Corporation V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
The Disposable Resuscitators with optional built-in pr Terminated |
BTM | None listed |
| Nov 1, 2012 | Ventlab Corporation Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
The Disposable Resuscitators with optional built-in Terminated |
BTM | None listed |
| Nov 1, 2012 | Ventlab Corporation AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
The Disposable Resuscitators with optional built-in pre Terminated |
BTM | None listed |
| 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 | None listed |
| Nov 1, 2012 | Ventlab Corporation Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. Terminated |
BTM | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.