Cleared Traditional

K934067 - POWRPAK REPLACEMENT BATTERIES FOR PHISI...

K934067 is an FDA 510(k) clearance for POWRPAK REPLACEMENT BATTERIES FOR PHISI..., manufactured by National Custom Ent., Inc.. The device is a Class 3 Cardiovascular device with product code DRK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

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

FDA 510(k) Submission Details - K934067

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.

DRK Device Classification - Class 3, Premarket Approval

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.