Cleared Traditional

K853135 - VISITEC 2 MICRON FLUID FILTER

K853135 is an FDA 510(k) clearance for VISITEC 2 MICRON FLUID FILTER, manufactured by Visitec Co.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K853135 · Visitec Co. · Ophthalmic device
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Aug 1985
Decision
14d
Days
Class 2
Risk

K853135 is an FDA 510(k) clearance for the VISITEC 2 MICRON FLUID FILTER. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 14 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 Visitec Co. devices

FDA 510(k) Submission Details - K853135

510(k) Number K853135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1985
Decision Date August 09, 1985
Days to Decision 14 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
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K853135.
STORZ IAS DISPOSABLE PACK
K853430 · Storz Instrument Co. · Dec 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · Visitec Co. · Dec 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · CooperVision, Inc. · 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