Cleared Traditional

K812544 - RELIANCE OPHTHALMIC INSTRUMENT CONTROL

K812544 is an FDA 510(k) clearance for RELIANCE OPHTHALMIC INSTRUMENT CONTROL, manufactured by F. & F. Koenigkramer. The device is a Class 1 Ophthalmic device with product code HMF cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812544 · F. & F. Koenigkramer · Ophthalmic device
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Sep 1981
Decision
17d
Days
Class 1
Risk

K812544 is an FDA 510(k) clearance for the RELIANCE OPHTHALMIC INSTRUMENT CONTROL. Classified as Stand, Instrument, Ac-powered, Ophthalmic (product code HMF), Class I - General Controls.

Submitted by F. & F. Koenigkramer (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1860 - 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 F. & F. Koenigkramer devices

FDA 510(k) Submission Details - K812544

510(k) Number K812544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1981
Decision Date September 21, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 110d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

HMF Device Classification - Class 1, General Controls

Product Code HMF Stand, Instrument, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1860
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 - HMF Stand, Instrument, Ac-powered, Ophthalmic

Devices cleared under the same product code (HMF) and FDA review panel - the closest regulatory comparables to K812544.
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