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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 1999 | K991953 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION Engineered Medical Systems | BTM |
| Sep 18, 1998 | K982215 | MANUAL RESUSCITATOR WITH ACE Medical Marketing Concepts | BTM |
| Jul 16, 1998 | K980066 | CPR FILTERSHIELD Plasco, Inc. | BTM |
| Jul 6, 1998 | K981308 | INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG International Respiratory Systems, Inc. | BTM |
| Jul 6, 1998 | K981307 | INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR International Respiratory Systems, Inc. | BTM |
| May 21, 1998 | K974141 | PLUS REUSABLE RESUSCITATOR Schiff & Co. | BTM |
| Mar 25, 1998 | K973419 | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR Nellcor Puritan Bennett, Inc. | BTM |
| Jan 29, 1998 | K973106 | GOLEMB DISPOSABLE BAG MASK RESUSCITATOR Allied Healthcare Products, Inc. | BTM |
| Dec 2, 1997 | K971243 | OHMEDA INFANT RESUSCITATION SYSTEM Ohmeda Medical | BTM |
| Oct 31, 1997 | K970756 | MERCURY MEDICAL REUSABLE CPR BAG Mercury Medical | BTM |
| Sep 17, 1997 | K972283 | SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT Sims | BTM |
| Sep 3, 1997 | K972139 | ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP Davis & Geck, Inc. | BTM |
| Jul 7, 1997 | K963848 | MANUAL RESUSCITATOR Owens-Brigam Medical Co. | BTM |
| Jun 16, 1997 | K970991 | DATEX ENGSTOM MANUAL RESUSCITATOR Promedic, Inc. | BTM |
| Jun 13, 1997 | K970959 | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) Instrumentation Industries, Inc. | BTM |
| May 15, 1997 | K964584 | AMBU SPUR NEONATE Ambu, Inc. | BTM |
| Feb 21, 1997 | K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR Hudson Respiratory Care, Inc. | BTM |
| Aug 15, 1996 | K955507 | GRAYCO POCKET PUMP Grayco, Inc. | BTM |
| Jul 2, 1996 | K961330 | BAGRIGHT INFANT RESUSCITATOR Medical Marketing Concepts | BTM |
| Jul 2, 1996 | K961329 | BAGRIGHT CHILD RESUSCITATOR Medical Marketing Concepts | BTM |
| Jun 28, 1996 | K961882 | RESPOSABLE INFANT RESUSCITATOR Medical Marketing Concepts | BTM |
| Jun 28, 1996 | K961868 | RESPOSABLE CHILD RESUSCITATOR Medical Marketing Concepts | BTM |
| Jun 28, 1996 | K961369 | BAGRIGHT RESPOSABLE RESUSCITATOR Medical Marketing Concepts | BTM |
| Jun 28, 1996 | K961332 | BAGRIGHT RESPOSABLE INFANT RESUSCITATOR Medical Marketing Concepts | BTM |
| Jun 28, 1996 | K961331 | BAGRIGHT RESPOSABLE CHILD RESUSCITATOR Medical Marketing Concepts | BTM |
| Apr 26, 1996 | K960468 | DMR/CO2 COMBO KTI Nellcor Puritan Bennett, Inc. | BTM |
| Feb 29, 1996 | K953546 | MANUAL PULMONARY RESUSICITATOR Medical Marketing Concepts | BTM |
| Jan 30, 1996 | K954866 | MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR Mercury Medical | BTM |
| Dec 20, 1995 | K954296 | BAGRIGHT RESUSCITATOR Medical Marketing Concepts | BTM |
| Dec 20, 1995 | K954150 | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Green Field Medical Sourcing, Inc. | BTM |
| Nov 22, 1995 | K953617 | RESPOSABLE RESUSCITATOR Medical Marketing Concepts | BTM |
| Sep 19, 1995 | K953824 | LIFEMASK FACE SHIELD Carefree Trading, Inc. | BTM |
| Aug 28, 1995 | K952512 | CAPNO-FLO REGULATOR, CAPNO-FLO Kirk Specialty Systems | BTM |
| Jun 8, 1995 | K952169 | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC Intertech Resources, Inc. | BTM |
| Jan 5, 1995 | K934699 | RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE Respironics, Inc. | BTM |
| Dec 21, 1994 | K944301 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 Hudson Respiratory Care, Inc. | BTM |
| Dec 12, 1994 | K944347 | PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR) Puritan Bennett Corp. | BTM |
| Oct 28, 1994 | K921982 | MATRX HOPE(R) 5 RESUSCITATOR Matrix Medica, Inc. | BTM |
| Aug 18, 1994 | K941037 | BNOS MICRO VENT, MODEL AC AND MODEL AO Reeves Manufactoring | BTM |
| Aug 11, 1994 | K943617 | DISPOSABLE MANUAL RESUSCITATOR Puritan-Bennett | BTM |
| May 6, 1994 | K940581 | BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS Respironics, Inc. | BTM |
| Dec 14, 1993 | K934310 | BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR Respironics, Inc. | BTM |
| Nov 24, 1993 | K922819 | INFANT DISPOSABLE BAG MASK RESUSCITATOR Life Support Products, Inc. | BTM |
| Nov 24, 1993 | K922691 | LSP (MODEL 554) BAG MASK RESUSCITATOR Life Support Products, Inc. | BTM |
| Oct 6, 1993 | K933626 | CAPNO-FLO Kirk Specialty Systems | BTM |
| Sep 3, 1993 | K932797 | PRESSURE LIMITING ELBOW Engineered Medical Systems | BTM |
| Apr 21, 1993 | K924671 | BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT Engineered Medical Systems | BTM |
| Apr 6, 1993 | K924610 | BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT Engineered Medical Systems | BTM |
| Mar 11, 1993 | K930429 | AID, CARDIOPULMONARY RESUSCITATION Valley Forge Scientific Corp. | BTM |
| Feb 5, 1993 | K923762 | SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE Ambu, Inc. | BTM |
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