Cleared Traditional

K801365 - KOLD WRAP

K801365 is an FDA 510(k) clearance for KOLD WRAP, manufactured by Romaine, Inc.. The device is a Class 1 Physical Medicine device with product code IME cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K801365 · Romaine, Inc. · Physical Medicine device
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Aug 1980
Decision
58d
Days
Class 1
Risk

K801365 is an FDA 510(k) clearance for the KOLD WRAP. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Romaine, Inc. (Walker, US). The FDA issued a Cleared decision on August 7, 1980 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5700 - 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 - K801365

510(k) Number K801365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1980
Decision Date August 07, 1980
Days to Decision 58 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
58d faster than avg
Panel avg: 116d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

IME Device Classification - Class 1, General Controls

Product Code IME Pack, Hot Or Cold, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5700
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 - IME Pack, Hot Or Cold, Reusable

All 26
Devices cleared under the same product code (IME) and FDA review panel - the closest regulatory comparables to K801365.
ACE COLD BANDAGE
K810402 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
REUSEABLE HOT & COLD PACKS
K810451 · Fred Sammons, Inc. · Mar 1981
COLD/HOT PACK
K803299 · W.G. Whitney Corp. · Jan 1981
COLD PACK #589
K801776 · Sunbeam Corp. · Aug 1980
TRU-COLD THERAPY PAK
K800917 · Tru-Eze Mfg. Co., Inc. · May 1980
ICE CONTAINER I.C.E.
K792182 · Delta Medical Industries · Nov 1979
K801365 · KOLD WRAP
Download PDF Romaine, Inc.