Cleared Traditional

K964289 - EYE FIXATION SPECULUM

K964289 is an FDA 510(k) clearance for EYE FIXATION SPECULUM, manufactured by Eyefix, Inc.. The device is a Class 1 Ophthalmic device with product code HNC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K964289 · Eyefix, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Dec 1996
Decision
50d
Days
Class 1
Risk

K964289 is an FDA 510(k) clearance for the EYE FIXATION SPECULUM. Classified as Specula, Ophthalmic (product code HNC), Class I - General Controls.

Submitted by Eyefix, Inc. (Rockville, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Eyefix, Inc. devices

FDA 510(k) Submission Details - K964289

510(k) Number K964289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date December 17, 1996
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

HNC Device Classification - Class 1, General Controls

Product Code HNC Specula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HNC Specula, Ophthalmic

All 7
Devices cleared under the same product code (HNC) and FDA review panel - the closest regulatory comparables to K964289.
OCULOSTAT
K981235 · Laser Center Dev. Corp. · Jul 1998
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ASNIS GUIDED SCREW SYSTEMS
K801969 · Howmedica Corp. · Aug 1980
FELDSTEIN BLEPHAROPLASTY CLIP SHARP P
K760847 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU
K760848 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976