Cleared Traditional

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 (K934067) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K934067 · National Custom Ent., Inc. · Cardiovascular device
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Oct 1993
Decision
48d
Days
Class 3
Risk

K934067 is an FDA 510(k) clearance for the POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10. Classified as Dc-defibrillator, High Energy, (including Paddles) (product code DRK), Class III - Premarket Approval.

Submitted by National Custom Ent., Inc. (Burnsville, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 48 days - a notably fast clearance 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: High-complexity regulatory submission. High regulatory complexity profile. 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 National Custom Ent., Inc. devices

Submission Details

510(k) Number K934067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1993
Decision Date October 07, 1993
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DRK Dc-defibrillator, High Energy, (including Paddles)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5300
Definition Pma To Be Filed By 12/26/96 (fr 50706 (9/27/96))
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.