Cleared Traditional

K901778 - 3M HEAT COMFORT PORTABLE SELF-HEATING PAD

K901778 is an FDA 510(k) clearance for 3M HEAT COMFORT PORTABLE SELF-HEATING PAD, manufactured by 3M Company. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K901778 · 3M Company · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
14d
Days
Class 1
Risk

K901778 is an FDA 510(k) clearance for the 3M HEAT COMFORT PORTABLE SELF-HEATING PAD. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on May 1, 1990 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 - K901778

510(k) Number K901778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date May 01, 1990
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 116d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 80
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K901778.
SHUR-LOCK ICE WRAP SYSTEM
K904819 · Conco Medical Co. · Dec 1990
LIBERTY HOT PACK AND LIBERTY KOLD PACK
K902839 · Liberty Ent. · Jul 1990
INSTANT ICE PACK
K901834 · Impact Packaging Corp. · May 1990
MEDI-PACK
K895860 · Heatmax Mfg., Inc. · Jan 1990
STAT-PAD
K894926 · Hettel Accessories, Inc. · Sep 1989
THERMO-PACK
K890924 · Medical Manufacturers, Inc. · Mar 1989
K901778 · 3M HEAT COMFORT PORTABLE SELF-HEATING PAD
Download PDF 3M Company