Cleared Traditional

K853430 - STORZ IAS DISPOSABLE PACK

K853430 is the FDA 510(k) clearance for STORZ IAS DISPOSABLE PACK by Storz Instrument Co.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K853430 · Storz Instrument Co. · Ophthalmic device
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Dec 1985
Decision
123d
Days
Class 2
Risk

K853430 is an FDA 510(k) clearance for the STORZ IAS DISPOSABLE PACK. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 123 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 Storz Instrument Co. devices

Submission Details

510(k) Number K853430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1985
Decision Date December 16, 1985
Days to Decision 123 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
13d slower than avg
Panel avg: 110d · This submission: 123d
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 47
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K853430.
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K854508 · Storz Instrument Co. · Feb 1986
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CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
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K853135 · Visitec Co. · Aug 1985