Cleared Traditional

K822599 - KEATES I/A SYSTEM FRIGITRONICS 4000

K822599 is the FDA 510(k) clearance for KEATES I/A SYSTEM FRIGITRONICS 4000 by Frigitronics of Connecticut, Inc.. It is a Class 2 Ophthalmic device (product code HKP) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K822599 · Frigitronics of Connecticut, Inc. · Ophthalmic device
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Oct 1982
Decision
40d
Days
Class 2
Risk

K822599 is an FDA 510(k) clearance for the KEATES I/A SYSTEM FRIGITRONICS 4000. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Frigitronics of Connecticut, Inc. (Walker, US). The FDA issued a Cleared decision on October 6, 1982 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Frigitronics of Connecticut, Inc. devices

Submission Details

510(k) Number K822599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1982
Decision Date October 06, 1982
Days to Decision 40 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 110d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKP Instrument, Vitreous Aspiration And Cutting, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HKP Instrument, Vitreous Aspiration And Cutting, Battery-powered

All 8
Devices cleared under the same product code (HKP) and FDA review panel - the closest regulatory comparables to K822599.
AARON VAC 2
K952558 · Aaron Medical Industries · Mar 1997
VISITEC VITRECTOMY UNIT
K896622 · Visitec Co. · Apr 1990
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K832074 · CooperVision, Inc. · Aug 1983
VITREOUS SUCTION/CUTTER
K791000 · Concept, Inc. · Sep 1979
STAT
K790893 · Varian Assoc., Inc. · Aug 1979
CLINITEX VIS-X ASPIRATING ACCESSORY
K780852 · Varian Assoc., Inc. · Nov 1978