Atlas FDA

KAI

9 FDA 510(k) clearances · Product code

28 daysmedian time to decision
93 days90th percentile
9clearances measured

FDA profile

Official device name
Mirror, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Medical specialty
Ear, Nose, Throat
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RecordFirmDate
ANTRUM & ATTIC MIRROR (K833601)Microtek Medical, Inc.1984-01-03
MIRROR TIP (K823915)Treace Medical, Inc.1983-01-21
BUCKINGHAM ATTIC & ANTRUM MIRROR (K822374)Treace Medical, Inc.1982-09-09
LARYNGEAL MIRRORS (K822261)Kelleher Corp.1982-08-30
HEAD MIRROR WITH HEADBAND (K822191)Kelleher Corp.1982-08-20
ATMOS MIRROR WARMER (K820354)Jedmed Instrument Co.1982-03-01
MIRROR WARMER (K781750)Arleton Technical Products, Inc.1979-01-17
MIRROR, NASO-PHARYNX (K770054)Welch Allyn, Inc.1977-01-18
MIRROR, LARYNGEAL (K770053)Welch Allyn, Inc.1977-01-18

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