Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAH — Predicate Candidate Screening
202 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
281 days90th percentile
202clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026-05-15 | 267 | 0 |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | 2026-04-30 | 342 | 0 |
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | 2024-11-14 | 185 | 0 |
| K222917 | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. | 2024-02-15 | 507 | 0 |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection | Passy-Muir, Inc. | 2023-09-16 | 205 | 0 |
| K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) | Intersurgical , Ltd. | 2023-06-15 | 237 | 0 |
| K221472 | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co., Ltd. | 2023-02-08 | 264 | 0 |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinS | Drägerwerk AG & Co. KGaA | 2022-12-07 | 167 | 4 |
| K221250 | EasyOne Filter | Ndd Medizintechnik AG | 2022-11-22 | 204 | 0 |
| K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022-03-27 | 412 | 0 |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moist | Pall Corporation | 2021-11-16 | 203 | 0 |
| K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Min | Pharma System AB | 2021-09-26 | 395 | 0 |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | 2020-03-23 | 250 | 0 |
| K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | 2020-03-16 | 171 | 1 |
| K182862 | Servo Guard | Maquet Critical Care AB | 2019-10-21 | 375 | 0 |
| K190022 | SafeBreath Filter Mouthpiece | MD Diagnostics Limited | 2019-09-25 | 264 | 0 |
| K163300 | ThermoShield HME Filter | Flexicare Medical Limited. | 2017-03-22 | 120 | 0 |
| K151498 | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | 2015-12-18 | 197 | 0 |
| K141087 | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGL | Intersurgical Incorporated | 2015-02-12 | 290 | 0 |
| K132709 | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | Vr Medical | 2014-07-30 | 335 | 0 |
| K132679 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | Galemed Corp. | 2014-04-18 | 233 | 0 |
| K131626 | EXCELERON BACTERIAL FILTERS | Exceleron Medical | 2014-02-26 | 267 | 0 |
| K133666 | RT016 INSPIRATORY FILTER | Fisher & Paykel Healthcare, Ltd. | 2014-02-05 | 68 | 0 |
| K130664 | HYRDROMAX HMEF | A-M Systems | 2013-06-21 | 101 | 0 |
| K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | Westmed, Inc. | 2012-12-06 | 212 | 0 |
| K121026 | FLO-GUARD BREATHING FILTER | Intersurgical, Inc. | 2012-11-02 | 212 | 0 |
| K112958 | HUMID-VENT HEPA | Teleflex Medical | 2012-09-21 | 352 | 0 |
| K110246 | MEDISIZE RED AND MEDISIZE BLUE | Qserve America, Inc. | 2011-11-04 | 281 | 0 |
| K111408 | MICROGARD II | Carefusion Germany 234 GmbH | 2011-10-17 | 151 | 0 |
| K102483 | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODE | Sunset Healthcare Solutions, LLC | 2011-09-13 | 379 | 0 |
| K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOIS | Intersurgical, Inc. | 2010-10-29 | 445 | 0 |
| K101629 | FIL 1520 | Glenn Medical Systems, Inc. | 2010-07-09 | 29 | 0 |
| K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCH | Intersurgical, Inc. | 2010-03-10 | 216 | 0 |
| K093426 | BACT-TRAP HEPA MIDI | Pharma Systems AB | 2010-02-22 | 111 | 0 |
| K091363 | COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF95 | Ag Industries | 2010-02-04 | 272 | 0 |
| K092218 | FLEXICARE BREATHING FILTERS | Flexicare Medical, Ltd. | 2009-10-06 | 76 | 0 |
| K090738 | THERMOFLO HCH, THERMOFLO FILTER | Arc Medical, Inc. | 2009-07-27 | 129 | 0 |
| K091185 | 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRA | Hsiner Co., Ltd. | 2009-07-24 | 92 | 0 |
| K081536 | MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED | Medisize BV | 2009-01-23 | 235 | 0 |
| K072002 | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR | Draeger Medical AG & Co. KG | 2008-01-31 | 192 | 0 |
| K063526 | A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER | A-M Systems, Inc. | 2007-06-29 | 219 | 2 |
| K063125 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | Arc Medical, Inc. | 2007-04-13 | 182 | 0 |
| K061426 | OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF | Porous Media Corp. | 2006-06-05 | 13 | 0 |
| K052087 | BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 | Ag Industries | 2005-12-14 | 134 | 0 |
| K050927 | RT019 INSPIRATORY/EXPIRATORY FILTER | Fisher & Paykel Healthcare, Ltd. | 2005-08-01 | 110 | 0 |
| K050953 | AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE | Air Safety, Ltd. | 2005-06-29 | 75 | 0 |
| K043120 | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI | Datex-Ohmeda, Inc. | 2005-03-01 | 109 | 0 |
| K043148 | ALL FLOW PULMONARY FUNCTION FILTER | Alliance Tech Medical, Inc. | 2004-12-13 | 28 | 0 |
| K032878 | KUNG SHIN, HMEF SK203 | Kung Shin Plastics Co., Ltd. | 2004-09-20 | 371 | 2 |
| K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | Intersurgical, Inc. | 2004-05-13 | 290 | 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