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
K830169Substantially Equivalent

Dorc Adjustable Image Contacts

JEDMED Instrument Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830169 is the FDA 510(k) clearance record for DORC ADJUSTABLE IMAGE CONTACTS, a class I device, cleared for Jedmed Instrument Co. on under FDA product code HKS (Prism, Gonioscopic). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K830169.

Clearance record

Decision date
Received
(20 days to decision)
Product code
HKS Prism, Gonioscopic
Regulation
21 CFR 886.1660
Device class
Class I
Review panel
Ophthalmic
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HKS

Trailing 12 months

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

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