Cleared Traditional

K942810 - PALCO LABS COLD POUCH

K942810 · Palco Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K942810

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
263d slower than avg
Panel avg: 115d · This submission: 378d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K942810.
CONTROLLED TEMPERATURE CABINET SYSTEM
K973747 · Smith · May 1998
ACU-HALT
K955661 · Glederer & Co., Inc. · Dec 1996
ACU-LAB
K955776 · Glederer & Co., Inc. · Jun 1996
NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
K925588 · North American Sterilization & Packaging Co. · Dec 1993
NORTEC STERILE WATER FOR DEVICE IRRIGATION
K925593 · North American Sterilization & Packaging Co. · Dec 1993
OLYMPIC WARMETTE
K911955 · Olympic Medical Corp. · Jul 1991