Cleared Traditional

K895813 - GLAUCOMA MECHANICAL TREPHINE

K895813 is the FDA 510(k) clearance for GLAUCOMA MECHANICAL TREPHINE by Trek Medical Products, Inc.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K895813 · Trek Medical Products, Inc. · Ophthalmic device
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Apr 1990
Decision
210d
Days
Class 2
Risk

K895813 is an FDA 510(k) clearance for the GLAUCOMA MECHANICAL TREPHINE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Trek Medical Products, Inc. (Muckwonago, US). The FDA issued a Cleared decision on April 30, 1990 after a review of 210 days - an extended review 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: 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 Trek Medical Products, Inc. devices

Submission Details

510(k) Number K895813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date April 30, 1990
Days to Decision 210 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 110d · This submission: 210d
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 29
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K895813.
DISPOSABLE POSTERIOR MICROSCISSORS
K920718 · Storz Instrument Co. · May 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745 · Storz Instrument Co. · Mar 1992
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K912384 · Nidek, Inc. · Dec 1991
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278 · Storz Instrument Co. · Aug 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · CooperVision, Inc. · Apr 1989
NIDEK CV-4000
K880929 · Nidek, Inc. · May 1988