Cleared Traditional

K810152 - X-VEE

K810152 is an FDA 510(k) clearance for X-VEE, manufactured by Temporaty Surgical Systems. The device is a Class 2 Ophthalmic device with product code HKP cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K810152 · Temporaty Surgical Systems · Ophthalmic device
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Mar 1981
Decision
55d
Days
Class 2
Risk

K810152 is an FDA 510(k) clearance for the X-VEE. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Temporaty Surgical Systems (Walker, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 55 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.

FDA 510(k) Submission Details - K810152

510(k) Number K810152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date March 17, 1981
Days to Decision 55 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 faster than avg
Panel avg: 110d · This submission: 55d
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 14
Devices cleared under the same product code (HKP) and FDA review panel - the closest regulatory comparables to K810152.
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K832074 · CooperVision, Inc. · Aug 1983
KEATES I/A SYSTEM FRIGITRONICS 4000
K822599 · Frigitronics of Connecticut, Inc. · Oct 1982
EMERGENCY POWER PAC (EMPAC)
K813273 · Optical Micro Systems, Inc. · Dec 1981
OCUTOME MODEL 8000
K791898 · Cooper Medical Devices Corp. · Oct 1979
VITREOUS SUCTION/CUTTER
K791000 · Concept, Inc. · Sep 1979
STAT
K790893 · Varian Assoc., Inc. · Aug 1979
K810152 · X-VEE
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