Cleared Traditional

K790394 - DEFIBRILLATOR INTERAL PADDLE TEST LOAD

K790394 is an FDA 510(k) clearance for DEFIBRILLATOR INTERAL PADDLE TEST LOAD, manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K790394 · Physio-Control Corp. · Cardiovascular device
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Mar 1979
Decision
25d
Days
Class 2
Risk

K790394 is an FDA 510(k) clearance for the DEFIBRILLATOR INTERAL PADDLE TEST LOAD. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Physio-Control Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1979 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5325 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Physio-Control Corp. devices

FDA 510(k) Submission Details - K790394

510(k) Number K790394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date March 23, 1979
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRL Device Classification - Class 2, Special Controls

Product Code DRL Tester, Defibrillator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5325
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 - DRL Tester, Defibrillator

Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K790394.
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