Cleared Traditional

K942810 - PALCO LABS COLD POUCH (FDA 510(k) Clearance)

K942810 · Palco Laboratories, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
378d
Days
-
Risk

K942810 is an FDA 510(k) clearance for the PALCO LABS COLD POUCH.

Submitted by Palco Laboratories, Inc. (Santa Cruz, US). The FDA issued a Cleared decision on June 28, 1995 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Palco Laboratories, Inc. devices

Submission Details

510(k) Number K942810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1994
Decision Date June 28, 1995
Days to Decision 378 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 114d · This submission: 378d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -