Cleared Traditional

K843146 - MICRO-TEMP PUMPS & MICRO-TEMP PADS

K843146 is an FDA 510(k) clearance for MICRO-TEMP PUMPS & MICRO-TEMP PADS, manufactured by Seabrook Medical Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K843146 · Seabrook Medical Systems, Inc. · Physical Medicine device
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Aug 1984
Decision
7d
Days
Class 2
Risk

K843146 is an FDA 510(k) clearance for the MICRO-TEMP PUMPS & MICRO-TEMP PADS. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Seabrook Medical Systems, Inc. (Walker, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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 Seabrook Medical Systems, Inc. devices

FDA 510(k) Submission Details - K843146

510(k) Number K843146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date August 17, 1984
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 43
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K843146.
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