Cleared Traditional

K820359 - HOT MINI 15 & HOT MINI 24

K820359 is an FDA 510(k) clearance for HOT MINI 15 & HOT MINI 24, manufactured by Hot Mini International, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K820359 · Hot Mini International, Inc. · Physical Medicine device

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Mar 1982

Decision

27d

Days

Class 1

Risk

K820359 is an FDA 510(k) clearance for the HOT MINI 15 & HOT MINI 24. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Hot Mini International, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1982 after a review of 27 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.

FDA 510(k) Submission Details - K820359

510(k) Number	K820359 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 1982
Decision Date	March 08, 1982
Days to Decision	27 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

89d faster than avg

Panel avg: 116d · This submission: 27d

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 77

Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K820359.

EIXO THERMUS HEATING PADS

K844224 · Eixo Thermus · Nov 1984

SPENCO CRYOPRESS

K820906 · Spenco Medical Corp. · May 1982

COMPRES PORTABLE HEAT PADS

K821046 · S.C. Johnson & Son, Inc. · Apr 1982

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

JAPANESE HOTZIE

K811803 · Consolidated Health & Sports Prod. · Jul 1981

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 K820359

Hot Mini International, Inc.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Hot Mini International, 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: March 8, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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