510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K873987Substantially Equivalent

Iras Glare Tester

Randwal Instrument Co., Inc., Southbridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873987 is the FDA 510(k) clearance record for IRAS GLARE TESTER, a class II device, cleared for Randwal Instrument Co., Inc. on under FDA product code HLJ (Ophthalmoscope, Battery-Powered). FDA records list 6 510(k) clearances for Randwal Instrument Co., Inc., from to . As of , FDA records show no recalls naming K873987.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HLJ Ophthalmoscope, Battery-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Randwal Instrument Co., Inc. 278 Worcester St., Southbridge MA
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