Atlas FDA

BYD

73 FDA 510(k) clearances · Product code

63 daysmedian time to decision
169 days90th percentile
73clearances measured

FDA profile

Official device name
Condenser, Heat And Moisture (Artificial Nose)
Device class
Class I (low risk)
Regulation
21 CFR 868.5375
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2020: 35 · 2021: 15 · 2022: 32 · 2023: 45 · 2025: 52 · 2026: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HEAT & MOISTURE EXCHANGER (K955008)Intertech Resources, Inc.1996-01-30
DISPOSABLE HME/FILTER (K954194)Engstrom Medical1995-10-20
HEAT MOISTURE EXCHANGER (K953580)Intertech Resources, Inc.1995-09-15
TYPE 1 & 2 (HUMIDAIR I & II) (K953507)Icor AB1995-09-07
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (K953544)Gibeck, Inc.1995-08-25
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (K953491)Gibeck, Inc.1995-08-25
WARM N WET HMEF W/LUER ADAPTER (K953620)Hospitak, Inc.1995-08-25
EEE (K953540)Edentec Corp.1995-08-25
WARM N WET HME W/LUER ADAPTER (K953619)Hospitak, Inc.1995-08-25
HUMID-VENT TRACH-VENT (K952845)Gibeck, Inc.1995-07-25
HUMID-VENT 2 (K952844)Gibeck, Inc.1995-07-20
HUMID-VENT 1 (K952750)Gibeck, Inc.1995-07-20
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE (K952823)Icor AB1995-07-13
HUMID-VENT FILTER PEDI (K952084)Gibeck, Inc.1995-06-12
FLEXLIFE (K952036)Mallinckrodt Medical1995-06-08
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (K946209)Med-Plastics Intl., Inc.1995-06-08
HUMID-VENT MICRO (K951856)Gibeck, Inc.1995-06-07
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT (K950447)Vital Signs, Inc.1995-02-21
AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H (K945359)Artema Medical AB1995-02-21
DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER (K945657)Tec II Medical, Inc.1994-12-07
HEAT AND MOISTURE EXCHANGER FILTER (HME) (K943915)Medicomp, Inc.1994-10-14
DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME (K944194)Med-Tek Innovations, Inc.1994-09-13
HYGROLIFE (K942794)Mallinckrodt Medical1994-08-22
HEAT AND MOISTURE EXCHANGERS AND FILTERS (K941987)Icor AB1994-08-15
AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF (K941436)Icor AB1994-06-08
VENSHIELD (K941813)Cybermedic, Inc.1994-05-03
HYGROSTER (K941585)Mallinckrodt Medical1994-04-19
TRACHEOLIFE (K941535)Mallinckrodt Medical1994-04-15
HEPA FILTERED HEAT AND MOISTURE EXCHANGER (K935036)Intertech Resources, Inc.1994-01-25
KING SYSTEMS HME (K934441)King Systems Corp.1993-12-02
HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION (K934190)Bird Life Design1993-11-24
AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH (K933597)Arthro-Medic, Inc.1993-11-01
FHB, FHB-T, FHBFLEX, FHBFLEX-T (K925622)Icor AB1993-05-26
VAPORTEMP HEAT AND MOISTURE EXCHANGER (K922946)Mallinckrodt Medical1993-03-08
5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID (K923865)Vital Signs, Inc.1993-02-01
HEAT MOISTURE CONDENSER (K923910)Concord/Portex1993-01-26
BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. (K915786)Helix Medical, Inc.1992-06-30
BREATHE EASY (K914336)Vital Signs, Inc.1992-03-25
FLOCARE DRY CAS SAMPLING PORT MODELS (K912700)Flocare Medical1991-09-11
FLOCARE LF-A (K912699)Flocare Medical1991-09-11
ARTEMA AQUA+ FLEX (K912336)Artema Medical AB1991-07-26
ARTEMA AQUA+ (K912333)Artema Medical AB1991-07-26
ARTEMA AQUA+ T & TS (K912334)Artema Medical AB1991-07-26
ARTEMA AQUA+ N (K912335)Artema Medical AB1991-07-26
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER (K903519)Intertech Resources, Inc.1990-12-13
ICOR HCH 4, ICOR HCH 7 (K904338)Icor AB1990-12-04
FLOCARE (K904193)Flocare Medical1990-11-29
FREEVENT (TM) (K903057)Pharma Systems, Inc.1990-11-20
BACT-HME (TM) (K903058)Pharma Systems, Inc.1990-11-09
HME-10 (TM) (K903054)Pharma Systems, Inc.1990-10-31
FLOCARE N (K902501)Flocare Medical1990-07-02
HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE (K900150)Icor AB1990-01-25
HUMIDI-FLEX TM (K885313)Life Design Systems, Inc.1989-10-11
FLOCARE (K893875)Mega-Tech Intl., Inc.1989-08-11
HUMID-VENT FILTER (K881657)Gibeck Respiration1988-06-24
HUMID-VENT 2 S FLEX (K881656)Gibeck Respiration1988-06-16
HUMID-VENT 2 S (K881644)Gibeck Respiration1988-06-10
BREATH-EASY (K881308)Icor AB1988-05-17
THERMOVENT 600, 1200, T, 02 (K874597)Portex, Inc.1988-01-19
HUMID-VENT(R) 2 PORT (K873768)Gibeck Respiration1987-11-24
HUMID-VENT(R) MINI (K873767)Gibeck Respiration1987-11-06
ICOR NEONATAL HCH (K872371)Icor AB1987-09-04
STOM-VENT (K872153)Gibeck Respiration1987-08-03
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F (K864095)Gambro, Inc.1987-02-20
HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER (K862020)Intertech/Ohio1986-06-30
AMERICAN PHARMASEAL HUMIDAIR CONDENSER (K854012)American Pharmaseal Div. Ahsc1985-12-03
SERVO HUMIDIFIER 153 (K852601)Siemens Elema AB1985-07-08
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB (K844040)Siemens Elema AB1984-10-25
PALL HEAT MOISTURE EXCHANGING FILTER (K834292)Pall Biomedical Products Co.1984-04-04
INLINE FOAM NOSE (K840398)Mallinckrodt Critical Care1984-03-16
FOAM NOSE (K840399)Mallinckrodt Critical Care1984-03-16
ENGSTOM EDITH (K821365)Lkb Instruments, Inc.1982-06-29
SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150 (K790681)Siemens Corp.1979-04-13

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Every clearance here is in the API, with alerts when new ones post.