510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984537Substantially Equivalent

Keratome System, Model K3000

Insight Technologies Instruments, LLC, Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984537 is the FDA 510(k) clearance record for KERATOME SYSTEM, MODEL K3000, a class I device, cleared for Insight Technologies Instruments, LLC on under FDA product code HMY (Keratome, Battery-Powered). FDA records list 2 510(k) clearances for Insight Technologies Instruments, LLC, from to . As of , FDA records show no recalls naming K984537.

Clearance record

Decision date
Received
(144 days to decision)
Product code
HMY Keratome, Battery-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Insight Technologies Instruments, LLC 264 Quarry Rd., Milford CT
510(k) summary
Statement
Third party review
No

Clearances, product code HMY

Trailing 12 months

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

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