Cleared Traditional

K940842 - UNIPOWER RECHARGEABLE BATTERY PACK

K940842 is the FDA 510(k) clearance for UNIPOWER RECHARGEABLE BATTERY PACK by Unipower Corp.. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K940842 · Unipower Corp. · Cardiovascular device
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Sep 1994
Decision
196d
Days
Class 2
Risk

K940842 is an FDA 510(k) clearance for the UNIPOWER RECHARGEABLE BATTERY PACK. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Unipower Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 Unipower Corp. devices

Submission Details

510(k) Number K940842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 23, 1994
Decision Date September 07, 1994
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 45
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K940842.
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K922315 · Physio-Control Corp. · Mar 1994
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