Cleared Traditional

K896622 - VISITEC VITRECTOMY UNIT

K896622 is an FDA 510(k) clearance for VISITEC VITRECTOMY UNIT, manufactured by Visitec Co.. The device is a Class 2 Ophthalmic device with product code HKP cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K896622 · Visitec Co. · Ophthalmic device
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Apr 1990
Decision
134d
Days
Class 2
Risk

K896622 is an FDA 510(k) clearance for the VISITEC VITRECTOMY UNIT. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 134 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 Visitec Co. devices

FDA 510(k) Submission Details - K896622

510(k) Number K896622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date April 04, 1990
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 110d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKP Device Classification - Class 2, Special Controls

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 K896622.
AARON VAC 2
K952558 · Aaron Medical Industries · Mar 1997
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