Cleared Traditional

K904896 - EYE PAD

K904896 is the FDA 510(k) clearance for EYE PAD by Ulti-Med Intl., Inc.. It is a Class 1 General & Plastic Surgery device (product code HMP) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K904896 · Ulti-Med Intl., Inc. · General & Plastic Surgery device
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Dec 1990
Decision
36d
Days
Class 1
Risk

K904896 is an FDA 510(k) clearance for the EYE PAD. Classified as Pad, Eye (product code HMP), Class I - General Controls.

Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on December 5, 1990 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4440 - the FDA general and plastic surgery 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 Ulti-Med Intl., Inc. devices

Submission Details

510(k) Number K904896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date December 05, 1990
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMP Pad, Eye
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4440
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 - HMP Pad, Eye

Devices cleared under the same product code (HMP) and FDA review panel - the closest regulatory comparables to K904896.
STERILE,DISPOSABLE EYE DRESSING
K921349 · Deroyal Industries, Inc. · May 1992
DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
K874411 · Keeler Instruments, Inc. · Jan 1988
DONALDSON NATURAL EYEPATCH
K860979 · Keeler Instruments, Inc. · Apr 1986
VISITEC EYE SHIELD
K843197 · Visitec Co. · Oct 1984
CONPHAR EYE PROTECTOR
K803145 · Conphar, Inc. · Feb 1981