Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTL · Predicate Candidate Screening
100 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
352 days90th percentile
100clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath hea | Draegerwerk AG & CO Kgaa | 2025-04-04 | 203 | 0 |
| K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | 2023-05-24 | 352 | 0 |
| K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | 2021-02-11 | 189 | 0 |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 | 367 | 0 |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | 2019-01-18 | 86 | 0 |
| K173373 | SafeT T-Piece Resuscitator | Ventlab, LLC | 2018-11-16 | 385 | 0 |
| K161420 | MOVES SLC | Thornhill Research, Inc. | 2017-06-06 | 379 | 0 |
| K162968 | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | 2017-04-10 | 168 | 0 |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | 2015-03-16 | 276 | 3 |
| K142096 | T-PIECE RESUSCITATOR | Mercury Medical | 2014-10-17 | 77 | 0 |
| K140049 | MOVES SLC | Thornhill Research, Inc. | 2014-05-29 | 140 | 0 |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | 2014-05-28 | 69 | 0 |
| K131098 | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-09 | 356 | 0 |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-02 | 274 | 0 |
| K132759 | VENTRAIN | Dolphys Medical B.V. | 2014-03-26 | 203 | 0 |
| K131877 | SAVE II, SAVE II BASIC | Automedx, Inc. | 2014-03-21 | 269 | 0 |
| K123957 | PNEUPAC PARAPAC PLUS | Smiths Medical International , Ltd. | 2013-09-16 | 269 | 6 |
| K112783 | MANUJET III | VBM Medizintechnik GmbH | 2011-12-22 | 87 | 0 |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | Atom Medical Corporation | 2011-04-06 | 215 | 0 |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | O-Two Medical Technologies, Inc. | 2010-05-06 | 140 | 0 |
| K093913 | MERCURY MEDICAL T-PIECE RESUSCITATOR | Mercury Medical, Inc. | 2010-04-06 | 105 | 2 |
| K093261 | MOVES | Thornhill Research, Inc. | 2010-03-26 | 158 | 2 |
| K092085 | ISPIRA RESUSCITATION UNIT | Neoforce Group, Inc. | 2009-10-07 | 90 | 0 |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | Allied Healthcare Products, Inc. | 2009-05-20 | 97 | 0 |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | Allied Healthcare Products, Inc. | 2009-05-18 | 173 | 0 |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | Allied Healthcare Products, Inc. | 2009-05-14 | 178 | 0 |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | O-Two Medical Technologies, Inc. | 2009-03-06 | 298 | 0 |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | Allied Healthcare Products, Inc. | 2008-08-15 | 218 | 0 |
| K080692 | MACS CPAP SYSTEM | Airon Corporation | 2008-06-20 | 101 | 0 |
| K073261 | VAR MONITOR | Vortran Medical Technology 1, Inc. | 2008-05-23 | 185 | 0 |
| K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | Allied Healthcare Products, Inc. | 2008-03-06 | 210 | 0 |
| K071527 | PNEUPAC VR1 AIR MIX | Smiths Medical International , Ltd. | 2007-10-04 | 122 | 0 |
| K071221 | SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 | Automedx, Inc. | 2007-09-06 | 127 | 0 |
| K070636 | AUTOVENT 4000 WITH CPAP | Allied Healthcare Products, Inc. | 2007-07-13 | 128 | 0 |
| K070120 | AUTOVENT MODEL 4000 | Allied Healthcare Products, Inc. | 2007-05-03 | 111 | 0 |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | Ohmeda Medical | 2007-04-20 | 88 | 5 |
| K051476 | UNI-VENT MODEL 73X | Impact Instrumentation, Inc. | 2005-10-28 | 147 | 0 |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | O-Two Medical Technologies, Inc. | 2005-09-28 | 117 | 0 |
| K051889 | CAREVENT CA AND DRA | O-Two Medical Technologies, Inc. | 2005-08-30 | 49 | 0 |
| K051322 | PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER | Smiths Medical International , Ltd. | 2005-08-05 | 77 | 1 |
| K043495 | BABYPAC | Smiths Medical International Ltd., Luton | 2005-04-22 | 126 | 0 |
| K041473 | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | Vortran Medical Technology 1, Inc. | 2004-07-15 | 43 | 2 |
| K040090 | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 PO | Pneupac , Ltd. | 2004-05-27 | 132 | 0 |
| K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | Impact Instrumentation, Inc. | 2004-03-26 | 235 | 0 |
| K030803 | PARAPAC 200D TRANSPORT, MODEL V200D | Pneupac , Ltd. | 2003-09-29 | 200 | 0 |
| K021841 | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER | Pneupac , Ltd. | 2003-07-17 | 407 | 0 |
| K020899 | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P | Pneupac , Ltd. | 2002-12-13 | 268 | 0 |
| K021520 | EMT-CPAP | Emergency Medical Techology | 2002-07-15 | 66 | 0 |
| K001430 | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 200 | Vortran Medical Technology 1, Inc. | 2000-07-05 | 61 | 2 |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET | Instrumentation Industries, Inc. | 1999-08-17 | 84 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda