Cleared Traditional

K946080 - PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K946080 · Portable Power Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
232d
Days
Class 1
Risk

K946080 is an FDA 510(k) clearance for the PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR. Classified as Box, Battery, Rechargeable (product code FCO), Class I - General Controls.

Submitted by Portable Power Systems, Inc. (Castle Rock, US). The FDA issued a Cleared decision on August 2, 1995 after a review of 232 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Portable Power Systems, Inc. devices

Submission Details

510(k) Number K946080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date August 02, 1995
Days to Decision 232 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 130d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCO Box, Battery, Rechargeable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.