Product code KAI— Ear, Nose, Throat

FDA has cleared 9 devices under product code KAI between 1977 and 1984, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19841 clearance
• 19831 clearance
• 19824 clearances
• 19791 clearance
• 19772 clearances

• Welch Allyn, Inc.2 clearances
• Treace Medical, Inc.2 clearances
• Kelleher Corp.2 clearances
• Microtek Medical, Inc.1 clearance
• Jedmed Instrument Co.1 clearance
• Arleton Technical Products, Inc.1 clearance

• K833601 — ANTRUM & ATTIC MIRRORMicrotek Medical, Inc.·1984-01-03
• K823915 — MIRROR TIPTreace Medical, Inc.·1983-01-21
• K822374 — BUCKINGHAM ATTIC & ANTRUM MIRRORTreace Medical, Inc.·1982-09-09
• K822261 — LARYNGEAL MIRRORSKelleher Corp.·1982-08-30
• K822191 — HEAD MIRROR WITH HEADBANDKelleher Corp.·1982-08-20
• K820354 — ATMOS MIRROR WARMERJedmed Instrument Co.·1982-03-01
• K781750 — MIRROR WARMERArleton Technical Products, Inc.·1979-01-17
• K770053 — MIRROR, LARYNGEALWelch Allyn, Inc.·1977-01-18
• K770054 — MIRROR, NASO-PHARYNXWelch Allyn, Inc.·1977-01-18