510(k) K953546 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MANUAL PULMONARY RESUSICITATOR
| Applicant | Medical Marketing Concepts, Hardy VA, US |
| Decision | Substantially Equivalent, Feb 29, 1996 |
| Received | Jul 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| May 24, 2018 | Sun Med, LLC STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 Terminated |
BTM | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.