Cleared Traditional

K912367 - EYE BUBBLE

K912367 is an FDA 510(k) clearance for EYE BUBBLE, manufactured by Aaron Medical Industries. The device is a Class 1 Ophthalmic device with 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

FDA 510(k) Submission Details - K912367

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.

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 15
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K912367.
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465 · National Healthcare Mfg. Corp. · Jun 1997
SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085 · American Threshold Industries, Inc. · Nov 1993
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