Cleared Traditional

K912522 - OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEE...

K912522 is an FDA 510(k) clearance for OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEE..., manufactured by Summit Technology, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K912522 · Summit Technology, Inc. · Ear, Nose, Throat device
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Jul 1991
Decision
64d
Days
Class 1
Risk

K912522 is an FDA 510(k) clearance for the OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Summit Technology, Inc. (Waltham, US). The FDA issued a Cleared decision on July 25, 1991 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - the FDA ear, nose and throat 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 Summit Technology, Inc. devices

FDA 510(k) Submission Details - K912522

510(k) Number K912522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1991
Decision Date July 25, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 89d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

EQH Device Classification - Class 1, General Controls

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EQH Source, Carrier, Fiberoptic Light

All 25
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K912522.
LX 150 LIGHT SOURCE
K922095 · Welch Allyn, Inc. · Jul 1992
ASPIRATING ENDO OCULAR PROBE
K914247 · Surgical Technologies, Inc. · Dec 1991
KAPS 90 DEGREE FIBEROPTIC ADAPTOR
K912885 · Jedmed Instrument Co. · Aug 1991
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · Jedmed Instrument Co. · Jan 1990
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · Aspen Laboratories, Inc. · Feb 1986
VENT TUBE FORCEPS
K831589 · Treace Medical, Inc. · Jun 1983