Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CBP — Predicate Candidate Screening
103 FDA 510(k) clearances under this product code; the 50 most recent screened below.
151 daysmedian FDA review time
309 days90th percentile
103clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Serie | Dehas Medical Systems GmbH | 2024-10-29 | 168 | 0 |
| K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 | 231 | 0 |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | 2021-12-23 | 265 | 0 |
| K192285 | CPR Face Shield | Firstar Healthcare Company Limited (Guangzhou) | 2020-11-25 | 461 | 0 |
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | 2019-04-05 | 480 | 0 |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Withou | Xiamen Compower Medical Tech. Co., Ltd. | 2017-11-17 | 140 | 0 |
| K152521 | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | 2016-06-03 | 274 | 0 |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015-07-09 | 287 | 0 |
| K142402 | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | 2015-03-23 | 208 | 0 |
| K132143 | EXHALATION VALVE | Intersurgical Incorporated | 2014-06-04 | 328 | 0 |
| K112126 | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | 2011-12-01 | 129 | 0 |
| K111191 | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND | Wet Nose Technologies, LLC | 2011-07-28 | 91 | 0 |
| K102299 | CPR FACE MASK | Genuine First Aid, LLC | 2011-03-18 | 217 | 0 |
| K083418 | CPR MASK | Firstar Healthcare Co., Ltd. | 2010-07-22 | 611 | 2 |
| K091538 | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T | Wet Nose Technologies, LLC | 2010-03-25 | 303 | 0 |
| K082345 | OXYGEN DEMAND VALVE | Bpr Medical, Ltd. | 2009-03-13 | 210 | 0 |
| K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | Medsource International, LLC | 2008-08-26 | 88 | 0 |
| K052458 | LIV MEDICA CPR FACE MASK | Liv Medica Products Pvt. , Ltd. | 2006-07-07 | 303 | 0 |
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MO | Dynarex Corp. | 2005-12-22 | 83 | 1 |
| K042727 | POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A | Foremount Ent. Co., Ltd. | 2005-03-18 | 168 | 0 |
| K031397 | MERLIN E-MASK | Merlin Medical Limited | 2004-07-29 | 454 | 0 |
| K031431 | BAWMED RESCUE MASK | Bawmed UK | 2004-07-13 | 434 | 0 |
| K040366 | PRESSURE MANIFOLD, MODEL BC 110 | Fisher & Paykel Healthcare, Ltd. | 2004-03-04 | 20 | 0 |
| K030943 | MODIFICATION TO HIOX | Sensor Medics Corp. | 2003-04-22 | 27 | 0 |
| K023805 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | Laerdal Medical A/S | 2003-02-11 | 89 | 0 |
| K020665 | HI-OX | Sensor Medics Corp. | 2002-07-30 | 151 | 0 |
| K010191 | Y2000 POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | 2001-03-14 | 51 | 0 |
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | Laerdal Medical Corp. | 2000-10-06 | 120 | 0 |
| K993528 | RUSCH EMERGENCY MASK | Rusch, Inc. | 2000-05-31 | 226 | 0 |
| K991617 | FACE-2-FACE CPR PROTECTION SHIELD | Whiteline Plastics, Inc. | 1999-11-03 | 177 | 0 |
| K983631 | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P | Instrumentation Industries, Inc. | 1999-07-01 | 259 | 0 |
| K983919 | EMS MOUTH TO MASK RESUSCITATORS | Engineered Medical Systems | 1999-04-07 | 154 | 0 |
| K984481 | EXHALATION VALVE | Intersurgical, Inc. | 1999-01-29 | 44 | 0 |
| K980725 | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS | Instrumentation Industries, Inc. | 1998-08-24 | 181 | 0 |
| K980052 | RESPAIDE | Emergency Filtration Products, Inc. | 1998-08-05 | 211 | 0 |
| K981169 | RONDEX CPR ISO-SHIELD | Rondex Products, Inc. | 1998-05-19 | 50 | 0 |
| K973066 | NON-REBREATHING 'T' (BE 117) | Instrumentation Industries, Inc. | 1998-02-03 | 169 | 0 |
| K970780 | ONE-WAY VALVE (WITH CONNECTOR) | Instrumentation Industries, Inc. | 1997-09-18 | 198 | 0 |
| K960587 | CPROTECTOR 2000 | Certified Safety Mfg., Inc. | 1997-07-21 | 525 | 0 |
| K963755 | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR | Spiracle Technology | 1997-04-08 | 202 | 0 |
| K960995 | CPR BIO-BARRIER FACESHEILD | O-Two Systems Intl., Inc. | 1997-01-07 | 301 | 0 |
| K955520 | RESCUE BREATHER | International Safety, Inc. | 1996-10-08 | 309 | 0 |
| K954426 | CPR LIFE MASK COMPACT BARRIER | Carefree Trading, Inc. | 1996-09-16 | 360 | 0 |
| K955634 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | Boston Medical Products, Inc. | 1996-06-10 | 182 | 0 |
| K953414 | CPR MICROMASK WITH OXYGEN INLET | Plasco, Inc. | 1996-03-20 | 244 | 0 |
| K953349 | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE | Spiracle Technology | 1996-02-29 | 227 | 0 |
| K953230 | CPR SUPER POCKET PACK | Formosa-Cj Health Business Corp. | 1996-02-14 | 219 | 0 |
| K953461 | CPR MASK & RELATED FAMILY KITS | Safetec of America, Inc. | 1996-01-04 | 164 | 0 |
| K951483 | CPR MICROMASK | Plasco, Inc. | 1995-10-19 | 203 | 0 |
| K940820 | PERSHIELD CPR DEVICE | Rabintex Industries, Ltd. | 1995-09-25 | 580 | 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