Cleared Traditional

K894926 - STAT-PAD

K894926 is an FDA 510(k) clearance for STAT-PAD, manufactured by Hettel Accessories, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K894926 · Hettel Accessories, Inc. · Physical Medicine device
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Sep 1989
Decision
34d
Days
Class 1
Risk

K894926 is an FDA 510(k) clearance for the STAT-PAD. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Hettel Accessories, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 34 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.

View all Hettel Accessories, Inc. devices

FDA 510(k) Submission Details - K894926

510(k) Number K894926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date September 05, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
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 35
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K894926.
ANAGO DISPOSABLE INSTANT COLD PACK
K926590 · Anago, Inc. · May 1993
CURAD KID SIZE INSTANT COLD PACK
K920252 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1992
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · 3M Company · May 1990
EXOTHERMIC HEATING PAD
K850637 · Travenol Laboratories, S.A. · Apr 1985
ACE BRAND INSTANT COLD PACK
K820282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1982
BK-7182 INSTANT COLD PACK
K813628 · Fred Sammons, Inc. · Jan 1982