Cleared Traditional

K950680 - INFANT HEEL WARMER

K950680 is the FDA 510(k) clearance for INFANT HEEL WARMER by Baxter Healthcare Corp. It is a Class 1 Physical Medicine device (product code IMD) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K950680 · Baxter Healthcare Corp · Physical Medicine device
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Aug 1995
Decision
190d
Days
Class 1
Risk

K950680 is an FDA 510(k) clearance for the INFANT HEEL WARMER. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 23, 1995 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K950680 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 14, 1995
Decision Date August 23, 1995
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 19
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K950680.
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770 · Allegiance Healthcare Corp. · Nov 1997
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
K970399 · Allegiance Healthcare Corp. · Apr 1997
ANDELA DYNAMIC COOLING DEVICE
K951033 · Candela Laser Corp. · Aug 1996
POLY-MEDICS HEAT PACK
K941245 · Biomet, Inc. · May 1994
PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
ANAGO FEM-COOL/FEM-COOL PETITE
K926137 · Anago, Inc. · May 1993