Cleared Traditional

K811577 - CROUCH CORNEAL PROTECTOR

K811577 is an FDA 510(k) clearance for CROUCH CORNEAL PROTECTOR, manufactured by Denver Biomedicals, Inc.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K811577 · Denver Biomedicals, Inc. · Ophthalmic device
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Aug 1981
Decision
63d
Days
Class 1
Risk

K811577 is an FDA 510(k) clearance for the CROUCH CORNEAL PROTECTOR. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Denver Biomedicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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 Denver Biomedicals, Inc. devices

FDA 510(k) Submission Details - K811577

510(k) Number K811577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1981
Decision Date August 07, 1981
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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 - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 12
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K811577.
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
K844761 · Medical Instrument Development Laboratories, Inc. · Dec 1984
STORZ UNIVERSAL EYE SHIELD
K841599 · Storz Instrument Co. · May 1984
NEONATE MASK FOR BABIES
K840444 · Richards Medical Co., Inc. · Mar 1984
FOX EYE SHIELDS
K810098 · American Hospital Supply Corp. · Feb 1981