Cleared Special

K112093 - CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER

K112093 is an FDA 510(k) clearance for CRYOMATIC CRYO CONSOLE, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HRN cleared through the Special 510(k) pathway after a 139-day FDA review.

K112093 · Keeler Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
139d
Days
Class 2
Risk

K112093 is an FDA 510(k) clearance for the CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER. Classified as Unit, Cryophthalmic, Ac-powered (product code HRN), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112093

510(k) Number K112093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2011
Decision Date December 08, 2011
Days to Decision 139 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 110d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

HRN Device Classification - Class 2, Special Controls

Product Code HRN Unit, Cryophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HRN Unit, Cryophthalmic, Ac-powered

All 9
Devices cleared under the same product code (HRN) and FDA review panel - the closest regulatory comparables to K112093.
PHAKOS Disposable Retinal Cryo Probe
K162756 · Phakos · May 2017
D.O.R.C. Disposable Cryo Probe
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K131787 · Keeler, Ltd. · Dec 2013
CRYOMATIC
K062412 · Keeler Instruments, Inc. · Nov 2006
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K012821 · Dutch Ophthalmic USA, Inc. · Oct 2001
KEELER CRYO MASTER & PROBES
K992954 · Keeler Instruments, Inc. · Dec 1999
K112093 · CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Download PDF FDA Summary Keeler Instruments, I…