Cleared Traditional

K905568 - TOPICAL COOLING PAD, MODEL 7000

K905568 is an FDA 510(k) clearance for TOPICAL COOLING PAD, manufactured by Daily Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K905568 · Daily Medical Products, Inc. · Cardiovascular device
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Jan 1991
Decision
42d
Days
Class 2
Risk

K905568 is an FDA 510(k) clearance for the TOPICAL COOLING PAD, MODEL 7000. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Daily Medical Products, Inc. (San Diego, US). The FDA issued a Cleared decision on January 23, 1991 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - the FDA cardiovascular device oversight 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 Daily Medical Products, Inc. devices

FDA 510(k) Submission Details - K905568

510(k) Number K905568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date January 23, 1991
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTR Heat-exchanger, Cardiopulmonary Bypass

All 86
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K905568.
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K896020 · Gish Biomedical, Inc. · May 1990
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K900640 · 3M Company · Apr 1990