Cleared Traditional

INSU COOL (K885055) - FDA 510(k) Clearance

K885055 · Dynex Trading Co. · General & Plastic Surgery device
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Apr 1989
Decision
140d
Days
-
Risk

K885055 is an FDA 510(k) clearance for the INSU COOL.

Submitted by Dynex Trading Co. (Oakland, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dynex Trading Co. devices

Submission Details

510(k) Number K885055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1988
Decision Date April 26, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -