Atlas FDA

CAT

42 FDA 510(k) clearances · Product code

27 daysmedian time to decision
98 days90th percentile
42clearances measured

FDA profile

Official device name
Cannula, Nasal, Oxygen
Device class
Class I (low risk)
Regulation
21 CFR 868.5340
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 128 · 2022: 74 · 2023: 116 · 2024: 75 · 2025: 81 · 2026: 48
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI (K011125)Hudson Respiratory Care, Inc.2001-06-13
NASAL CANNULA (K935533)Puritas Health Care, Inc.1994-02-03
4 SURE TM NASAL OXYGEN CANNULA (K922397)Boston Pacific Medical, Inc.1993-03-18
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (K921496)Alpine Specialties, Inc.1992-08-14
CANNULA NASAL OXYGEN (K920573)B & F Medical Products, Inc.1992-08-11
NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (K913421)Specialty Packaging Producs, Inc.1991-10-18
SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (K912197)Alpine Specialties, Inc.1991-08-20
SALTER LABS NEONATAL NASAL OXYGEN CANNULA (K911740)Salter Labs1991-07-24
CATHETER, NASAL, OXYGEN (K902420)Gainor Medical Europe, Ltd.1991-04-17
THE COMFORTABLE CANNULA (K896036)Comfortable Concepts Corp.1989-11-17
KENDALL CURITY OXYGEN NASAL CANNULA (K892435)The Kendal Co.1989-06-12
COMFORT STRAP (K884149)Comfort Strap Co.1988-10-21
OXYGEN CANNULA EAR WRAP (STYLE B) (K863432)Salter Labs1986-09-18
OXYGEN CANNULA EAR WRAP (STYLE A) (K863431)Salter Labs1986-09-18
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) (K860535)Andover Medical, Inc.1986-04-01
NASAL CANNULA W/2M & 5M TUBING (K860872)Dhd Medical Products Div. Diemolding Corp.1986-03-19
CANNULA BAND (K860261)T. G. & E. Medical1986-02-18
NASAL ONE (K852628)Ashai Co. , Ltd.1985-09-18
OXY-TUBE (K852625)Ashai Co. , Ltd.1985-09-18
OMNIMED NASAL OXYGEN CANNULA (K850066)Omni Intl., Inc.1985-01-24
PHARMA-PLAST NASAL OXYGEN CANNULA (K843467)Zimmar Consulting , Ltd.1984-11-19
STRAIGHT AND BUBBLE OXYGEN TUBING (K844083)Hudson Extrusions, Inc.1984-10-30
POLYVINYL CHLORIDE CANNULAS (K844084)Hudson Extrusions, Inc.1984-10-30
CHAD ADJUSTABLE CANNULA (K842968)Chad Therapeutics, Inc.1984-08-29
OXYGEN TUBING (K840897)Medical Technologies of Georgia1984-03-16
ARGYLE NASAL CANNULA (K833127)Sherwood Medical Co.1983-11-03
NASAL CANNULA (K823506)Seven Harvest Intl. Import & Export1982-12-09
OECO NASAL CANNULA (K811789)Oeco1981-07-02
NASAL CANNULA (K810342)Todd Industries, Inc.1981-03-17
SOF-TOUCH NASAL CANNULA CAT.#304 & 305 (K802062)Hospitak, Inc.1980-09-09
CONPHAR NASAL OXYGEN CANNULA-STERILE (K791247)Conphar, Inc.1979-07-24
NASAL, OXYGEN, CANNULA (K790885)Airlife, Inc.1979-05-17
CANNULAS, DYNACOR'S NASAL OXYGEN (K790056)Medline Industries, Inc.1979-02-05
CANNULA, NASAL, OXYGEN (K781415)Vitalab Products Corp.1978-09-07
NASAL OXYGEN CANNULA, #017207 (K771074)C.R. Bard, Inc.1977-08-04
OXYGEN CANNULA (K770996)Ohio Medical Products1977-06-29
LIGHTWEIGHT PLASTIC CANNULA (K770487)Hudson Oxygen Therapy Sales Co.1977-03-21
CANNULA, LARRIAT (K760551)Landmark Plastics1976-09-05
CANNULA, ARGYLE NASAL OXYGEN (K760337)Sherwood Medical Industries1976-08-11
CANNULA, DISPOSABLE OXYGEN TTHERAPY (K760330)Inhal-O-Tech Medical Plastic1976-08-04
CANNULAE, PLASTIC DISPOSABLE NASAL (K760218)Manner Medical Products1976-08-03
CANNULA, NASAL, FOR OXYGEN (K760080)Inspiron Corp.1976-07-15

Track CAT automatically

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