Cleared Traditional

K810451 - REUSEABLE HOT & COLD PACKS

K810451 is an FDA 510(k) clearance for REUSEABLE HOT & COLD PACKS, manufactured by Fred Sammons, Inc.. The device is a Class 1 Physical Medicine device with product code IME cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810451 · Fred Sammons, Inc. · Physical Medicine device
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Mar 1981
Decision
13d
Days
Class 1
Risk

K810451 is an FDA 510(k) clearance for the REUSEABLE HOT & COLD PACKS. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 13 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.

View all Fred Sammons, Inc. devices

FDA 510(k) Submission Details - K810451

510(k) Number K810451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1981
Decision Date March 04, 1981
Days to Decision 13 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: 115d · This submission: 13d
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 8
Devices cleared under the same product code (IME) and FDA review panel - the closest regulatory comparables to K810451.
HOT/COLD PACK HOLDERS
K823814 · Danek Medical, Inc. · Jan 1983
ATTACH-A-PAK
K821636 · Fred Sammons, Inc. · Jun 1982
ACE COLD BANDAGE
K810402 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
ICE CONTAINER I.C.E.
K792182 · Delta Medical Industries · Nov 1979
ICE PACK, REUSABLE FLEXIBLE
K790009 · Ackrad Laboratories · Jan 1979