Cleared Traditional

K912367 - EYE BUBBLE

K912367 is the FDA 510(k) clearance for EYE BUBBLE by Aaron Medical Industries. It is a Class 1 Ophthalmic device (product code HOY) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K912367 · Aaron Medical Industries · Ophthalmic device
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Oct 1991
Decision
126d
Days
Class 1
Risk

K912367 is an FDA 510(k) clearance for the EYE BUBBLE. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Aaron Medical Industries devices

Submission Details

510(k) Number K912367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date October 02, 1991
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 9
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K912367.
SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988
EYE GARD
K872000 · Treace Medical, Inc. · Jul 1987
HESSBURG LIGHT GUARD
K853035 · Visitec Co. · Dec 1985