Cleared Traditional

BURNS CASUALTY SHEET LIMB WRAP (K900443) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K900443 · Pilgrim Medical Services · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
154d
Days
Class 1
Risk

K900443 is an FDA 510(k) clearance for the BURNS CASUALTY SHEET LIMB WRAP. Classified as Sheet, Burn (product code FPY), Class I - General Controls.

Submitted by Pilgrim Medical Services (England Hr2 6sx, GB). The FDA issued a Cleared decision on July 3, 1990 after a review of 154 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5180 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pilgrim Medical Services devices

Submission Details

510(k) Number K900443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date July 03, 1990
Days to Decision 154 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 slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPY Sheet, Burn
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5180
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.