Cleared Traditional

FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 (K883822) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K883822 · Consolidated Industries of Greater Syracuse, Inc. · General & Plastic Surgery device
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Nov 1988
Decision
76d
Days
Class 1
Risk

K883822 is an FDA 510(k) clearance for the FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309. Classified as Pad, Eye (product code HMP), Class I - General Controls.

Submitted by Consolidated Industries of Greater Syracuse, Inc. (Syracuse, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 76 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 Consolidated Industries of Greater Syracuse, Inc. devices

Submission Details

510(k) Number K883822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received September 07, 1988
Decision Date November 22, 1988
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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.