Cleared Traditional

K932539 - DOCTOR DOWN --RESCUE WRAP

K932539 is an FDA 510(k) clearance for DOCTOR DOWN --RESCUE WRAP, manufactured by Three Dog Down. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K932539 · Three Dog Down · General Hospital
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Nov 1993
Decision
160d
Days
Class 1
Risk

K932539 is an FDA 510(k) clearance for the DOCTOR DOWN --RESCUE WRAP. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Three Dog Down (Cincinnati, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 160 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Three Dog Down devices

FDA 510(k) Submission Details - K932539

510(k) Number K932539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date November 02, 1993
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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 - KME Bedding, Disposable, Medical

All 26
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K932539.
READY-HEAT BLANKET
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RECEIVING BLANKET
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DEPEND UNDERPAD
K870522 · Kimberly-Clark Corp. · Mar 1987
KIMLON DISPOSABLE BLANKET
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