Cleared Traditional

CARDIO-PAK LAPAROTOMY PACK (K923233) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923233 · Cardio-Med-Associates, Inc. · General & Plastic Surgery device
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Mar 1993
Decision
262d
Days
Class 2
Risk

K923233 is an FDA 510(k) clearance for the CARDIO-PAK LAPAROTOMY PACK. Classified as Apparatus, Air Handling, Room (product code FZH), Class II - Special Controls.

Submitted by Cardio-Med-Associates, Inc. (Billings, US). The FDA issued a Cleared decision on March 20, 1993 after a review of 262 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5070 - the FDA general and plastic surgery 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: 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 Cardio-Med-Associates, Inc. devices

Submission Details

510(k) Number K923233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 01, 1992
Decision Date March 20, 1993
Days to Decision 262 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
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZH Apparatus, Air Handling, Room
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 General & Plastic Surgery devices follow this clearance model.