Cleared Traditional

K160591 - D.O.R.C. Disposable Cryo Probe

K160591 is an FDA 510(k) clearance for D.O.R.C. Disposable Cryo Probe, manufactured by Dutch Ophthalmic Research Center International BV. The device is a Class 2 Ophthalmic device with product code HRN cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K160591 · Dutch Ophthalmic Research Center International BV · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
328d
Days
Class 2
Risk

K160591 is an FDA 510(k) clearance for the D.O.R.C. Disposable Cryo Probe. Classified as Unit, Cryophthalmic, Ac-powered (product code HRN), Class II - Special Controls.

Submitted by Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on January 23, 2017 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dutch Ophthalmic Research Center International BV devices

FDA 510(k) Submission Details - K160591

510(k) Number K160591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date January 23, 2017
Days to Decision 328 days
Submission Type Traditional
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
218d slower than avg
Panel avg: 110d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 8
Devices cleared under the same product code (HRN) and FDA review panel - the closest regulatory comparables to K160591.
MIRA Adapter
K200911 · Phakos · Jun 2020
Frigitronics adapter
K180195 · Phakos · Mar 2018
PHAKOS Disposable Retinal Cryo Probe
K162756 · Phakos · May 2017
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
K131787 · Keeler, Ltd. · Dec 2013
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093 · Keeler Instruments, Inc. · Dec 2011
CRYOMATIC
K062412 · Keeler Instruments, Inc. · Nov 2006