Cleared Traditional

GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER (K880871) - FDA 510(k) Clearance

Class I Physical Medicine device.

K880871 · John Wagner Associates, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
80d
Days
Class 1
Risk

K880871 is an FDA 510(k) clearance for the GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by John Wagner Associates, Inc. (Concord, US). The FDA issued a Cleared decision on May 20, 1988 after a review of 80 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 John Wagner Associates, Inc. devices

Submission Details

510(k) Number K880871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 20, 1988
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 81
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K880871.
InfaTherm Disposable Infant Warming Mattress
K221653 · International Biomedical · Oct 2022
INFANT HEEL WARMER
K950680 · Baxter Healthcare Corp · Aug 1995
POLY-MEDICS HEAT PACK
K941245 · Biomet, Inc. · May 1994
PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · 3M Company · May 1990
EXOTHERMIC HEATING PAD
K850637 · Travenol Laboratories, S.A. · Apr 1985