Cleared Traditional

K834437 - KEATES IRRIGATION/ASPIRATION/VITREOUS

K834437 is the FDA 510(k) clearance for KEATES IRRIGATION/ASPIRATION/VITREOUS by Frigitronics of Connecticut, Inc.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K834437 · Frigitronics of Connecticut, Inc. · Ophthalmic device
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Mar 1984
Decision
102d
Days
Class 2
Risk

K834437 is an FDA 510(k) clearance for the KEATES IRRIGATION/ASPIRATION/VITREOUS. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Frigitronics of Connecticut, Inc. (Walker, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Frigitronics of Connecticut, Inc. devices

Submission Details

510(k) Number K834437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date March 30, 1984
Days to Decision 102 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 110d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 37
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K834437.
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · Visitec Co. · Dec 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · CooperVision, Inc. · Aug 1985
VISITEC 2 MICRON FLUID FILTER
K853135 · Visitec Co. · Aug 1985
DISPOSABLE OCUTOME PROBE
K833371 · CooperVision, Inc. · Jan 1984
DORC COMPACT MICRO SURGICAL SYSTEM
K830216 · Jedmed Instrument Co. · Mar 1983
COOPER VISION I/A SYSTEM III MODEL 1500
K822220 · CooperVision, Inc. · Oct 1982