Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYD — Predicate Candidate Screening
73 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
169 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955008 | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | 1996-01-30 | 90 | 0 |
| K954194 | DISPOSABLE HME/FILTER | Engstrom Medical | 1995-10-20 | 44 | 0 |
| K953580 | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | 1995-09-15 | 45 | 0 |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | 1995-09-07 | 43 | 0 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | 1995-08-25 | 28 | 0 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | 1995-08-25 | 31 | 0 |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 | 22 | 0 |
| K953540 | EEE | Edentec Corp. | 1995-08-25 | 28 | 0 |
| K953619 | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 | 22 | 0 |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | 1995-07-25 | 34 | 0 |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | 1995-07-20 | 29 | 0 |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | 1995-07-20 | 35 | 0 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T W | Icor AB | 1995-07-13 | 23 | 0 |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | 1995-06-12 | 40 | 0 |
| K952036 | FLEXLIFE | Mallinckrodt Medical | 1995-06-08 | 38 | 0 |
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | 1995-06-08 | 169 | 0 |
| K951856 | HUMID-VENT MICRO | Gibeck, Inc. | 1995-06-07 | 47 | 0 |
| K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | Vital Signs, Inc. | 1995-02-21 | 18 | 0 |
| K945359 | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | Artema Medical AB | 1995-02-21 | 111 | 0 |
| K945657 | DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER | Tec II Medical, Inc. | 1994-12-07 | 20 | 0 |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | Medicomp, Inc. | 1994-10-14 | 64 | 0 |
| K944194 | DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME | Med-Tek Innovations, Inc. | 1994-09-13 | 15 | 0 |
| K942794 | HYGROLIFE | Mallinckrodt Medical | 1994-08-22 | 69 | 0 |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | Icor AB | 1994-08-15 | 112 | 0 |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | Icor AB | 1994-06-08 | 76 | 0 |
| K941813 | VENSHIELD | Cybermedic, Inc. | 1994-05-03 | 21 | 0 |
| K941585 | HYGROSTER | Mallinckrodt Medical | 1994-04-19 | 19 | 0 |
| K941535 | TRACHEOLIFE | Mallinckrodt Medical | 1994-04-15 | 16 | 1 |
| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | Intertech Resources, Inc. | 1994-01-25 | 118 | 0 |
| K934441 | KING SYSTEMS HME | King Systems Corp. | 1993-12-02 | 83 | 0 |
| K934190 | HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION | Bird Life Design | 1993-11-24 | 90 | 0 |
| K933597 | AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH | Arthro-Medic, Inc. | 1993-11-01 | 98 | 0 |
| K925622 | FHB, FHB-T, FHBFLEX, FHBFLEX-T | Icor AB | 1993-05-26 | 201 | 0 |
| K922946 | VAPORTEMP HEAT AND MOISTURE EXCHANGER | Mallinckrodt Medical | 1993-03-08 | 263 | 0 |
| K923865 | 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID | Vital Signs, Inc. | 1993-02-01 | 182 | 0 |
| K923910 | HEAT MOISTURE CONDENSER | Concord/Portex | 1993-01-26 | 175 | 0 |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | Helix Medical, Inc. | 1992-06-30 | 189 | 0 |
| K914336 | BREATHE EASY | Vital Signs, Inc. | 1992-03-25 | 180 | 0 |
| K912700 | FLOCARE DRY CAS SAMPLING PORT MODELS | Flocare Medical | 1991-09-11 | 84 | 0 |
| K912699 | FLOCARE LF-A | Flocare Medical | 1991-09-11 | 84 | 0 |
| K912336 | ARTEMA AQUA+ FLEX | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K912333 | ARTEMA AQUA+ | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K912334 | ARTEMA AQUA+ T & TS | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K912335 | ARTEMA AQUA+ N | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K903519 | INTERTECH(TM) HEAT AND MOISTURE EXCHANGER | Intertech Resources, Inc. | 1990-12-13 | 132 | 0 |
| K904338 | ICOR HCH 4, ICOR HCH 7 | Icor AB | 1990-12-04 | 75 | 0 |
| K904193 | FLOCARE | Flocare Medical | 1990-11-29 | 78 | 0 |
| K903057 | FREEVENT (TM) | Pharma Systems, Inc. | 1990-11-20 | 132 | 0 |
| K903058 | BACT-HME (TM) | Pharma Systems, Inc. | 1990-11-09 | 121 | 0 |
| K903054 | HME-10 (TM) | Pharma Systems, Inc. | 1990-10-31 | 112 | 1 |
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