Cleared Traditional

K873918 - HEAD & CHIN RESTS

K873918 is the FDA 510(k) clearance for HEAD & CHIN RESTS by Richmond Products, Inc.. It is a Class 1 Ophthalmic device (product code HRH) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K873918 · Richmond Products, Inc. · Ophthalmic device
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Oct 1987
Decision
34d
Days
Class 1
Risk

K873918 is an FDA 510(k) clearance for the HEAD & CHIN RESTS. Classified as Trephine, Manual, Ophthalmic (product code HRH), Class I - General Controls.

Submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 34 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 Richmond Products, Inc. devices

Submission Details

510(k) Number K873918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1987
Decision Date October 28, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRH Trephine, Manual, 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 - HRH Trephine, Manual, Ophthalmic

Devices cleared under the same product code (HRH) and FDA review panel - the closest regulatory comparables to K873918.
DEKNATEL (R) TREPHINE
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K781411 · Codman & Shurtleff, Inc. · Sep 1978
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K771866 · Edward Weck, Inc. · Nov 1977