Cleared Traditional

K780852 - CLINITEX VIS-X ASPIRATING ACCESSORY

K780852 is an FDA 510(k) clearance for CLINITEX VIS-X ASPIRATING ACCESSORY, manufactured by Varian Assoc., Inc.. The device is a Class 2 Ophthalmic device with product code HKP cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K780852 · Varian Assoc., Inc. · Ophthalmic device
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Nov 1978
Decision
165d
Days
Class 2
Risk

K780852 is an FDA 510(k) clearance for the CLINITEX VIS-X ASPIRATING ACCESSORY. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978 after a review of 165 days - an extended review 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: 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 Varian Assoc., Inc. devices

FDA 510(k) Submission Details - K780852

510(k) Number K780852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1978
Decision Date November 03, 1978
Days to Decision 165 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
55d slower than avg
Panel avg: 110d · This submission: 165d
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 10
Devices cleared under the same product code (HKP) and FDA review panel - the closest regulatory comparables to K780852.
EMERGENCY POWER PAC (EMPAC)
K813273 · Optical Micro Systems, Inc. · Dec 1981
VITREOUS SUCTION/CUTTER
K791000 · Concept, Inc. · Sep 1979
STAT
K790893 · Varian Assoc., Inc. · Aug 1979
VITEROUS SUCTION CUTTER
K761353 · Concept, Inc. · Jan 1977
VISC X-VITREOUS ASPIRATING & CUT. INSTR
K760684 · Varian Assoc., Inc. · Oct 1976