Cleared Traditional

K921349 - STERILE,DISPOSABLE EYE DRESSING

K921349 is an FDA 510(k) clearance for STERILE, manufactured by Deroyal Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HMP cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K921349 · Deroyal Industries, Inc. · General & Plastic Surgery device
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May 1992
Decision
71d
Days
Class 1
Risk

K921349 is an FDA 510(k) clearance for the STERILE,DISPOSABLE EYE DRESSING. Classified as Pad, Eye (product code HMP), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 71 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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K921349

510(k) Number K921349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date May 29, 1992
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

HMP Device Classification - Class 1, General Controls

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

All 8
Devices cleared under the same product code (HMP) and FDA review panel - the closest regulatory comparables to K921349.
EYE PAD
K940333 · Certified Safety Mfg., Inc. · Mar 1994
EYE PAD
K904896 · Ulti-Med Intl., Inc. · Dec 1990
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