Cleared Traditional

K042145 - READY-HEAT BLANKET

K042145 is an FDA 510(k) clearance for READY-HEAT BLANKET, manufactured by Techtrade, LLC. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K042145 · Techtrade, LLC · General Hospital
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Sep 2004
Decision
39d
Days
Class 1
Risk

K042145 is an FDA 510(k) clearance for the READY-HEAT BLANKET. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Techtrade, LLC (Potomac, US). The FDA issued a Cleared decision on September 17, 2004 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042145

510(k) Number K042145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date September 17, 2004
Days to Decision 39 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 129d · This submission: 39d
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 54
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K042145.
OREX MEDICAL BEDDING
K944953 · Thantex Specialties, Inc. · Dec 1994
DISPOSE-A-SHEET
K933636 · Belmac Healthcare Corp. · Jan 1994
DOCTOR DOWN --RESCUE WRAP
K932539 · Three Dog Down · Nov 1993
AMERICAN BURN SHEET
K922143 · American Silk Sutures, Inc. · Aug 1992
FOIL BABY BUNTING
K915303 · Gam Industries, Inc. · Feb 1992
CHEM-SLEEVE B
K912257 · Haz-Med, Inc. · Dec 1991
K042145 · READY-HEAT BLANKET
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