Atlas FDA

BTQ

19 FDA 510(k) clearances · Product code

32 daysmedian time to decision
154 days90th percentile
19clearances measured

FDA profile

Official device name
Airway, Nasopharyngeal
Device class
Class I (low risk)
Regulation
21 CFR 868.5100
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2020: 13 · 2021: 20 · 2022: 20 · 2023: 24 · 2024: 22 · 2025: 60
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
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (K940320)Ad-Tech Medical Instrument Corp1995-09-19
NASOPHARYNGEAL AIRWAY (K921353)Coast Medical Corp.1992-06-11
NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (K911784)North American Sterilization & Packaging Co.1991-09-23
ROBERTAZZI NASOPHARYNGEAL AIRWAY (K903618)Eastmed Enterprises, Inc.1991-01-08
POLAMEDCO NASOPAHARYNGEAL AIRWAY (K900456)Polamedco, Inc.1990-04-19
CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (K901279)Chatham Industries1990-03-28
SUNDERLAND NASAL TUBE (K883668)Exmoor Plastics , Ltd.1988-11-21
RORERTAZZI NASOPHARYNGEAL AIRWAY (K873949)Penn Medical Devices, Inc.1987-10-20
NASOPHARYNGEAL AIRWAY (K871673)Harding Industries, Inc.1987-06-15
STERILE NASOPHARYNGEAL AIRWAY (K853162)Inmed Corp.1985-08-06
NASOPHARYNGEAL AIRWAY-ROBERTAZZI (K850644)Dryden Corp.1985-03-21
LINDER NASOPHARYNGEAL AIRWAY (K843524)Polamedco, Inc.1984-10-04
NASOPHARYNGEAL AIRWAYS (K841093)Inmed Corp.1984-03-23
SILICONE RUGGER DISPOSABLE YOKE-CPAP (K834078)Vesta, Inc.1983-12-27
NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE (K831476)Fls Medical Products, Inc.1983-06-10
AIRWAYS & NASOPHARYNGEAL TYPE (K830983)Medovations, Inc.1983-05-09
NASOPHARYNGEAL AIRWAY (K810960)Vesta, Inc.1981-04-23
SILICONE RUBBER-BI NASOPHARYNGEAL AIR (K792018)Vesta, Inc.1979-11-13
AIRWAY, ARGYLE NASOPHARYNGEAL (K760125)Sherwood Medical Industries1976-07-19

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