510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112093Substantially Equivalent

Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter

Keeler Instruments, Inc., Broomall PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112093 is the FDA 510(k) clearance record for CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER, a class II device, cleared for Keeler Instruments, Inc. on under FDA product code HRN (Unit, Cryophthalmic, Ac-Powered). FDA records list 60 510(k) clearances for Keeler Instruments, Inc., from to . As of , FDA records show no recalls naming K112093.

Clearance record

Decision date
Received
(139 days to decision)
Product code
HRN Unit, Cryophthalmic, Ac-Powered
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Keeler Instruments, Inc. 456 Pkwy., Broomall PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRN

Trailing 12 months

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

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