Cleared Traditional

K830981 - MICROPAK MOIST HEAT PAD

K830981 is an FDA 510(k) clearance for MICROPAK MOIST HEAT PAD, manufactured by Micropak Manufacturers, Inc.. The device is a Class 1 Physical Medicine device with product code IME cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K830981 · Micropak Manufacturers, Inc. · Physical Medicine device

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Jun 1983

Decision

66d

Days

Class 1

Risk

K830981 is an FDA 510(k) clearance for the MICROPAK MOIST HEAT PAD. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Micropak Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 66 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 - K830981

510(k) Number	K830981 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 1983
Decision Date	June 03, 1983
Days to Decision	66 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

50d faster than avg

Panel avg: 116d · This submission: 66d

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 21

Devices cleared under the same product code (IME) and FDA review panel - the closest regulatory comparables to K830981.

RE-HEATER, HOT PACK

K863654 · K & L Ent. · Oct 1986

NICE PACK

K832193 · Universal Medical Instrument Corp. · Aug 1983

ENSWELL

K831899 · Dr. Micheal A. Sabia · Jul 1983

ICY COLD ICE CAP

K830416 · Ladora Ent. · Mar 1983

THERMOELASTOMER HOT/COLD COMPRESS BK7186

K823649 · Fred Sammons, Inc. · Jan 1983

THERMOELASTOMER HOT/COLD COMPRESS-7187-

K823650 · Fred Sammons, Inc. · Jan 1983

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K830981

Micropak Manufacturers, Inc.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Micropak Manufacturers, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: June 3, 1983. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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