510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093495Substantially Equivalent

Otoscope and Ophthalmoscope Diagnostic Instrument Kits

American Diagnostic Corp., Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K093495 is the FDA 510(k) clearance record for OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS, a class II device, cleared for American Diagnostic Corp. on under FDA product code HLJ (Ophthalmoscope, Battery-Powered). FDA records list 39 510(k) clearances for American Diagnostic Corp., from to . As of , FDA records show no recalls naming K093495.

Clearance record

Decision date
Received
(374 days to decision)
Product code
HLJ Ophthalmoscope, Battery-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
American Diagnostic Corp. 55 Commerce Dr., Hauppauge NY
510(k) summary
Statement
Third party review
No

Clearances, product code HLJ

Trailing 12 months

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

FDA records show no clearances under product code HLJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLJ, 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