Cleared Traditional

K933065 - BATTERY PACK# S1009LA (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933065 · Portable Power Systems, Inc. · Cardiovascular device
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Feb 1994
Decision
240d
Days
Class 2
Risk

K933065 is an FDA 510(k) clearance for the BATTERY PACK# S1009LA. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Castle Rock, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 240 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 K933065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date February 17, 1994
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
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 574
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