Cleared Traditional

K212763 - UniVit HE

K212763 is an FDA 510(k) clearance for UniVit HE, manufactured by Visioncare Devices, LLC. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K212763 · Visioncare Devices, LLC · Ophthalmic device
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Aug 2022
Decision
344d
Days
Class 2
Risk

K212763 is an FDA 510(k) clearance for the UniVit HE, UniVit UHS. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Visioncare Devices, LLC (Anderson, US). The FDA issued a Cleared decision on August 10, 2022 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Visioncare Devices, LLC devices

FDA 510(k) Submission Details - K212763

510(k) Number K212763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2021
Decision Date August 10, 2022
Days to Decision 344 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 110d · This submission: 344d
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 K212763.
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488 · Storz Instrument Co. · Mar 1998
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743 · Storz Instrument Co. · Feb 1997
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K960061 · Storz Instrument Co. · Sep 1996
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
K954816 · Storz Instrument Co. · Mar 1996
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575 · Storz Instrument Co. · Sep 1995
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K953576 · Storz Instrument Co. · Sep 1995