Cleared Traditional

K883681 - DAS SPORT PUMP(TM)

K883681 is an FDA 510(k) clearance for DAS SPORT PUMP(TM), manufactured by D.A. Schulman, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K883681 · D.A. Schulman, Inc. · Physical Medicine device
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Sep 1988
Decision
32d
Days
Class 2
Risk

K883681 is an FDA 510(k) clearance for the DAS SPORT PUMP(TM). Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by D.A. Schulman, Inc. (Brooklyn Park, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 32 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 D.A. Schulman, Inc. devices

FDA 510(k) Submission Details - K883681

510(k) Number K883681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date September 30, 1988
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 44
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K883681.
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