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 |
|---|---|---|---|
| Nov 16, 1988 | K884068 | PULMANEX TM (NEO-NATAL SIZE) Life Design Systems, Inc. | BTM |
| Sep 14, 1988 | K883434 | AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) Ambu, Inc. | BTM |
| Aug 16, 1988 | K882285 | NONREBREATHING CIRCUIT Dryden Corp. | BTM |
| Aug 15, 1988 | K881207 | RES-Q 1, 2, 3, 4 AND 5 Nova-Ventrx | BTM |
| Jun 23, 1988 | K881686 | CPR BAG Devolve Corp. | BTM |
| Jun 16, 1988 | K882278 | RESUSCITATION BAG CONTROLLER (RBC) Physician Engineered Products, Inc. | BTM |
| Apr 14, 1988 | K881087 | LIFEGUARD SINGLE USE MANUAL RESUSCITATORS Lifeguard Medical Products, Inc. | BTM |
| Apr 14, 1988 | K881086 | LIFEGUARD MOUTH TO MASK RESUSCITATOR Lifeguard Medical Products, Inc. | BTM |
| Mar 4, 1988 | K880450 | RESUSCI PATIENT FACE SHIELD Laerdal Medical Corp. | BTM |
| Feb 29, 1988 | K880394 | FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR Intertech/Ohio | BTM |
| Feb 29, 1988 | K874567 | RESUSCITATOR American Medical Technology, Inc. | BTM |
| Jan 22, 1988 | K874418 | LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470 Life Support Products, Inc. | BTM |
| Jan 19, 1988 | K875077 | HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. Herco Products, Inc. | BTM |
| Jan 19, 1988 | K874321 | SOLCO SILICONE RESUSCITATOR Kahn-Tact U.S.A., Inc. | BTM |
| Oct 26, 1987 | K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR Hospitak, Inc. | BTM |
| Sep 28, 1987 | K873043 | MOUTH TO FACE RESUSCITATOR Artec Environmental Monitoring Division | BTM |
| Apr 20, 1987 | K871147 | MODIFIED CPREVIVER Augerscope, Inc. | BTM |
| Mar 9, 1987 | K864308 | BAUMAN CPR/RESPIRATOR General Medical Products, Inc. | BTM |
| Feb 26, 1987 | K864125 | CPREVIVER Augerscope, Inc. | BTM |
| Aug 26, 1986 | K863026 | PULMANEX TM (MODIFICATION) Life Design Systems, Inc. | BTM |
| Mar 27, 1986 | K860693 | PULMANEX (TM) Life Design Systems, Inc. | BTM |
| Mar 6, 1986 | K860180 | MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR Life Support Products, Inc. | BTM |
| Nov 1, 1985 | K854037 | PULMANEX Life Design Systems, Inc. | BTM |
| Sep 6, 1985 | K851171 | COMBIBAG MANUAL RESUSCITATOR Frontline Medical Corp. | BTM |
| Jul 8, 1985 | K852096 | RESUS-AID DISPOSABLE RESUSCITATION SHIELD Emergency Situation Products | BTM |
| Mar 25, 1985 | K844729 | RESUSCITATOR, PULMONARY, MANUAL Life Design Systems, Inc. | BTM |
| Feb 26, 1985 | K850436 | STAT BLUE DISPOS. MANUAL RESUSCITATOR Vital Signs, Inc. | BTM |
| Dec 17, 1984 | K844420 | MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR Med-Life, Inc. | BTM |
| Sep 27, 1984 | K843223 | FLOW CONTROLLER Precision Medical, Inc. | BTM |
| Aug 10, 1984 | K842693 | RESPIRONICS VENTEASY Respironics, Inc. | BTM |
| Jul 27, 1984 | K842696 | LIFE-MASK INFANT RESUSCITATOR Electronic Monitors, Inc. | BTM |
| Jul 6, 1984 | K842487 | SAMSON'S NEWBORN LUNG INFLATOR 340-1000 J. H. Emerson Co. | BTM |
| Apr 24, 1984 | K841496 | FRASER HARLAKE HOPE III RESUSCITATOR Fraser Harlake, Inc. | BTM |
| Apr 5, 1984 | K840935 | MANUAL RESUSCITATION SYSTEM Inspiron Corp. | BTM |
| Feb 10, 1984 | K840349 | MARK III RESUSCITATOR Ambu, Inc. | BTM |
| Jan 18, 1984 | K834250 | RESCUE MASK Rondex Products, Inc. | BTM |
| Jan 13, 1984 | K834400 | FLYNN III-CHILD BAG-MASK UNIT ETC O-Two Systems Intl., Inc. | BTM |
| Nov 29, 1983 | K833244 | REVIVE Aladdin Industries, Inc. | BTM |
| Sep 29, 1983 | K832495 | FLYNN SERIES III BAG/MASK UNIT- O-Two Systems Intl., Inc. | BTM |
| Sep 8, 1983 | K831885 | CODE BLUE MANUAL RESUSCITATOR Vital Signs, Inc. | BTM |
| Aug 12, 1983 | K831486 | SC-603 TWIN VALVE Instrumentation Industries, Inc. | BTM |
| Jun 24, 1983 | K831198 | CPR HEARTSAVER AND BREATHOLATOR Cervco Corp. | BTM |
| Jan 21, 1983 | K823710 | DISPOSABLE AIRWAY ADEJUNCT Groves Medical Supply, Inc. | BTM |
| Dec 7, 1982 | K823408 | BE#1000-INSTANT ON/OFF O2 VALVE Instrumentation Industries, Inc. | BTM |
| Oct 28, 1982 | K822213 | SIEMENS-ELEMA AB AGA REVIVATOR Siemens Elema AB | BTM |
| Aug 20, 1982 | K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT Laerdal Medical Corp. | BTM |
| Mar 26, 1982 | K820059 | RESUSCITATION MASK Cederroth, Inc. USA | BTM |
| Aug 25, 1981 | K812273 | RESUSCITATION CIRCUIT Vital Signs, Inc. | BTM |
| Jul 31, 1981 | K812022 | ZEE MANUAL RESUSCITATOR Zee Medical Products Co., Inc. | BTM |
| Feb 12, 1981 | K803066 | DISPOSABLE BAG MASK ADEJUNCT T. S. Enterprises, Inc. | BTM |
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