Cleared Traditional

K914221 - KPE 220 TS

K914221 is an FDA 510(k) clearance for KPE 220 TS, manufactured by Ipax, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K914221 · Ipax, Inc. · Ophthalmic device
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Oct 1991
Decision
63d
Days
Class 2
Risk

K914221 is an FDA 510(k) clearance for the KPE 220 TS, NONSTERILE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on October 25, 1991 after a review of 63 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 Ipax, Inc. devices

FDA 510(k) Submission Details - K914221

510(k) Number K914221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date October 25, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
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 51
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