Cleared Traditional

K934439 - RECHARGEABLE BATTERY PACK FOR CRITIKON ...

K934439 is the FDA 510(k) clearance for RECHARGEABLE BATTERY PACK FOR CRITIKON ... by Portable Power Systems, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K934439 · Portable Power Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
178d
Days
Class 2
Risk

K934439 is an FDA 510(k) clearance for the RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Parker, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Portable Power Systems, Inc. devices

Submission Details

510(k) Number K934439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date February 17, 1994
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K934439.
DATEX AS/3 PATIENT MONITOR
K933156 · Datex Division Instrumentarium Corp. · Dec 1994
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
K935394 · Marquette Electronics, Inc. · Oct 1994
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994
CRITIKON CENTRAL STATIN MONITOR
K933404 · Critikon Company, LLC · Feb 1994
THE ACTA FORMULA
K922703 · Biosound, Inc. · Apr 1993
MORTARA INSTRUMENT, INC. E-SCRIBE
K930558 · Mortara Instrument, Inc. · Apr 1993