Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BTM — Predicate Candidate Screening
209 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
267 days90th percentile
209clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical AS | 2025-11-24 | 180 | 0 |
| K243861 | butterflyBVM | Compact Medical, Inc. | 2025-04-25 | 130 | 0 |
| K221841 | EOlife® | Archeon | 2023-03-18 | 267 | 0 |
| K212905 | Sotair Device | Safe Bvm Corporation | 2022-08-18 | 339 | 0 |
| K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | 2021-08-26 | 205 | 0 |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, A | Flexicare Medical Limited. | 2018-12-07 | 175 | 0 |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable | Foremount Enterprise Co., Ltd. | 2018-05-11 | 431 | 0 |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resu | Ambu A/S | 2016-08-29 | 329 | 1 |
| K132172 | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | 2015-01-15 | 549 | 0 |
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical | 2012-01-13 | 87 | 0 |
| K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Ambu A/S | 2011-01-28 | 121 | 0 |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Neoforce Group, Inc. | 2011-01-06 | 114 | 0 |
| K094003 | REVIVATOR | Hersill, S.L. | 2010-09-17 | 263 | 0 |
| K093081 | POCKET BVM | Microbvm Systems , Ltd. | 2010-02-05 | 127 | 0 |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VA | Galemed Corp. | 2008-10-15 | 83 | 0 |
| K073410 | SAVE RESUSCITATOR | Artivent Corporation | 2008-09-12 | 283 | 0 |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | 2008-01-31 | 83 | 0 |
| K072021 | NEOPIP INFANT RESUSCITATOR | Neoforce Group, Inc. | 2007-09-12 | 51 | 0 |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Ohmeda Medical | 2007-04-20 | 85 | 5 |
| K062080 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | 2006-10-18 | 89 | 0 |
| K053466 | HSINER RESUSCITATOR | Hsiner Co., Ltd. | 2006-03-22 | 99 | 0 |
| K053140 | AMBU MARK IV RESUSCITATOR | Ambu A/S | 2005-12-23 | 44 | 0 |
| K053142 | AMBU MARK IV BABY RESUSCITATOR | Ambu A/S | 2005-12-20 | 41 | 0 |
| K051177 | PVC AND SILICONE MANUAL RESUSCITATORS | David Medical Products Co.,Ltd | 2005-08-29 | 115 | 0 |
| K042556 | SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-10 | Enter Medical Corporation | 2005-03-11 | 172 | 0 |
| K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | Ambu, Inc. | 2004-11-15 | 47 | 0 |
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCI | Ambu, Inc. | 2004-11-12 | 29 | 1 |
| K032596 | STURDY MANUAL RESUSCITATOR | Sturdy Industrial Co., Ltd. | 2004-08-05 | 349 | 0 |
| K031395 | MERLIN RESUSCITATOR | Merlin Medical Limited | 2004-07-16 | 441 | 0 |
| K031434 | BAWMED E-Z BAG RESUSCITATOR | Bawmed UK | 2004-02-06 | 276 | 0 |
| K030864 | VADI MANUAL RESUSCITATOR | Vedi Corp. | 2004-01-30 | 318 | 0 |
| K021328 | SMART BAG MO | O-Two Systems International, Inc. | 2003-06-26 | 426 | 0 |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | Portex, Inc. | 2003-02-11 | 90 | 0 |
| K023494 | NELLCOR INDGO MANUAL RESUSCITATOR | Nellcor Puritan Bennett, Inc. | 2003-02-07 | 112 | 0 |
| K021446 | OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INF | Oemedic International, Inc. | 2002-10-11 | 158 | 0 |
| K021716 | SIMPLIFY COMPACT RESUSCITATOR | Polymed (Xiamen) Plastic Industrial Co., Ltd. | 2002-10-08 | 138 | 0 |
| K012271 | ACUTEVENTILATOR | Impoex International, Ltd. | 2002-10-04 | 442 | 0 |
| K021390 | PMX COMPACT RESUCITATOR | Cheen Houng Ent. Co. , Ltd. | 2002-10-04 | 155 | 0 |
| K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR | Allied Healthcare Products, Inc. | 2002-10-01 | 295 | 0 |
| K021442 | OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, I | Oemedic International, Inc. | 2002-07-30 | 85 | 0 |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Portex, Inc. | 2002-02-27 | 75 | 3 |
| K012842 | V*CARE MANUAL RESUSCITATOR | Ventlab Corp. | 2001-09-18 | 26 | 21 |
| K003927 | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUG | Cheen Houng Ent. Co. , Ltd. | 2001-06-26 | 188 | 0 |
| K002846 | HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR | Headstar Medical Products Co., Ltd. | 2001-06-06 | 267 | 0 |
| K993278 | AMBU NEONATE SILICONE RESUSCITATOR | Ambu, Inc. | 2000-05-17 | 230 | 0 |
| K993194 | RUSCH MANUAL RESUSCITATOR BAG | Rusch, Inc. | 2000-03-24 | 183 | 0 |
| K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST R | Sims Portex, Inc. | 2000-01-18 | 231 | 0 |
| K992057 | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008 | Sims Portex, Inc. | 1999-09-13 | 87 | 0 |
| K991955 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL | Engineered Medical Systems | 1999-07-06 | 35 | 0 |
| K991953 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL | Engineered Medical Systems | 1999-07-01 | 30 | 0 |
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