510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801638Substantially Equivalent

A O Custom II Chair and Stand

American Optical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801638 is the FDA 510(k) clearance record for A O CUSTOM II CHAIR AND STAND, a class I device, cleared for American Optical Corp. on under FDA product code HME (Chair, Ophthalmic, Ac-Powered). FDA records list 35 510(k) clearances for American Optical Corp., from to . As of , FDA records show no recalls naming K801638.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HME Chair, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1140
Device class
Class I
Review panel
Ophthalmic
Applicant
American Optical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HME

Trailing 12 months

FDA records hold no clearances under product code HME in the trailing twelve months.

FDA records show no clearances under product code HME in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HME, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260