Cleared Traditional

K952558 - AARON VAC 2

K952558 is the FDA 510(k) clearance for AARON VAC 2 by Aaron Medical Industries. It is a Class 2 Ophthalmic device (product code HKP) cleared through the Traditional 510(k) pathway after a 656-day FDA review.

K952558 · Aaron Medical Industries · Ophthalmic device
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Mar 1997
Decision
656d
Days
Class 2
Risk

K952558 is an FDA 510(k) clearance for the AARON VAC 2. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 656 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Aaron Medical Industries devices

Submission Details

510(k) Number K952558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date March 19, 1997
Days to Decision 656 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
546d slower than avg
Panel avg: 110d · This submission: 656d
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 7
Devices cleared under the same product code (HKP) and FDA review panel - the closest regulatory comparables to K952558.
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
VITEROUS SUCTION CUTTER
K761353 · Concept, Inc. · Jan 1977