Atlas FDA

CAE

57 FDA 510(k) clearances · Product code

49 daysmedian time to decision
232 days90th percentile
57clearances measured

FDA profile

Official device name
Airway, Oropharyngeal, Anesthesiology
Device class
Class I (low risk)
Regulation
21 CFR 868.5110
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 62 · 2022: 51 · 2023: 52 · 2024: 59 · 2025: 61 · 2026: 32
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
LMA FAMILY OF AIRWAYS (K130304)The Laryngeal Mask Co., Ltd.2014-05-30
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 (K033189)King Systems Corp.2004-05-04
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (K033186)King Systems Corp.2004-04-14
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (K021634)King Systems Corp.2003-01-09
CUFFED OROPHARYNGEAL AIRWAY (COPA) (K955721)Mallinckrodt Medical1997-03-28
RUSCH OPTOSAFE (K960240)Rusch Intl.1996-04-19
KEISEI (K950613)Keisei (Usa) Co., Ltd.1996-02-14
GUEDEL AIRWAY (K953400)Mallinckrodt Medical1995-10-24
STB GUEDEL AIRWAY (K933760)Save-T-Breath Distributors C.C.1994-03-23
BERMAN AIRWAY (K936134)Smiths Industries Medical Systems, Inc.1994-01-28
GUEDEL AIRWAY (K922748)Oem Medical Div.1992-07-10
BERMAN INTUBATING/PHARYNGEAL AIRWAY (K913680)Chain Plastics Operations, Inc.1991-10-10
INTAVENT LARYNGEAL MASK (K904834)Intavent Intl. S.A.1991-07-26
KISS OF LIFE (K891926)Anthony Don Michael, M.D.1989-08-21
GOETTINGER EMERGENCY RESUSCITATION TUBE (K892123)Plastic Parts Corp.1989-07-14
ORAL AIRWAY (K891586)Dynarex Corp.1989-05-11
RESPAKIT (K892053)Protectical Health & Safety , Ltd.1989-04-27
BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES (K890566)Medi-Source, Inc.1989-03-15
#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY (K883593)Ecolab, Inc.1988-09-30
RESUS-AID (K881065)Applied Convergent Technologies, Inc.1988-07-14
'HILT-WAY' RESUSCITATOR (K880241)Medifield , Ltd.1988-03-31
THE PROTECTOR (K874412)Tri Jon, Inc.1988-02-12
MODIFIED C.P.R. MICROSHIELD (K871403)Westmark Enterprises, Inc.1987-05-04
RESUSIKIT (K861482)Begley Enterprises, Inc.1986-06-17
MEDTECH C.P.R. MASK (K862199)The Medtech Group, Inc.1986-06-13
DUAL-AID (K860949)Vitalograph , Ltd.1986-05-06
DISPOSABLE BERMAN AND GUEDEL AIRWAYS (K861540)Dryden Corp.1986-05-02
DISPOSABLE RESCUE BREATHING DEVICE (K861054)B & F Medical Products, Inc.1986-04-09
PLASTIC MOUTH BARRIER HCV-E (K860780)Westmark Enterprises, Inc.1986-04-02
CURITY FIBEROPTIC INTUBATING AIRWAY (K855137)The Kendal Co.1986-03-11
RESPIRATORY RESUSCITATION DEVICE (K854029)John H. Harrison1986-03-11
DISPOSABLE GUEDEL AIRWAY (K850248)Inmed Corp.1985-03-12
PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 (K844873)Pennine Medical , Ltd.1985-02-21
RESPIRONICS VENT EASY OXYGEN ENRICHME (K842605)Respironics, Inc.1984-07-27
MOUTH TO MASK EMERGENCY VENTILATION (K841429)O-Two Systems Intl., Inc.1984-04-17
RES-Q-MATE (K841120)Rsq Industries, Inc.1984-04-05
AIRWAY MASKS (K832512)Artec Environmental Monitoring Division1984-01-17
RESPIRONICS RESCUE DOME (K833328)Respironics, Inc.1983-12-16
WISDOM AIRWAY (K833482)Wisdom Corp.1983-12-05
BROOK LIFE SAVING AIRWAY DEVICE #900 & (K832435)La Societe Fianciere Senefin1983-10-04
ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III (K832471)Inmed Corp.1983-09-12
STRAITH ORAL AIRWAY (K831078)Surgical Technology Laboratories, Inc.1983-06-24
WILLIAMS AIRWAY INTUBATOR (K830767)Williams Airway Intubator1983-03-31
RESCUER (K822727)Armstrong Ind., Inc.1982-09-28
AIRWAYS (K820709)Seven Harvest Intl. Import & Export1982-06-25
ESPREE' GUEDEL ESPREE BERMAN AIRWAY (K821308)Esp Plastics, Inc.1982-05-21
7CM BERMAN AIRWAY (K820512)Vital Signs, Inc.1982-03-26
RIND AIRWAY (K812822)Rind Medical Development1981-11-16
ORAL AIRWAYS (K810651)First Industries, Inc.1981-03-31
THE LUOMANEN ORAL AIRWAY (K810123)Luomanen Medical Products1981-02-26
AIRWAYS-OROPHARYNGEAL (K810099)American Hospital Supply Corp.1981-02-05
STERILE AIRWAY (K810069)Medspec Corp.1981-02-02
DISPOSABLE BERMAN AIRWAYS (K800881)Harvard Laboratories1980-05-08
CONPHAR AIRWAYS (K791799)Conphar, Inc.1979-09-19
AIRWAYS (K780601)Abco Dealers, Inc.1978-05-19
AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (K770001)Omnicon Medical Corp.1977-01-12
AIRWAY, DUAL CHANNEL (K760488)Hudson Oxygen Therapy Sales Co.1976-09-03

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