Cleared Traditional

K895379 - LOW ENERGY DC - DEFIBRILLATOR (INCLUDIN...

K895379 is an FDA 510(k) clearance for LOW ENERGY DC - DEFIBRILLATOR (INCLUDIN..., manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K895379 · Physio-Control Corp. · Cardiovascular device
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Feb 1990
Decision
180d
Days
Class 2
Risk

K895379 is an FDA 510(k) clearance for the LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES). Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 180 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K895379

510(k) Number K895379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date February 26, 1990
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K895379.
MODEL #210 STEALTH DEFIB PADS
K904462 · Cardiotronics, Inc. · Dec 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478 · Physio-Control Corp. · Oct 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · Marquette Electronics, Inc. · Jul 1990
DEFIB K-PADS
K895662 · Katecho, Inc. · Jan 1990
MARQUETTE 1200 DEFIBRILLATION PADS
K895651 · Marquette Electronics, Inc. · Dec 1989
COORDINATOR
K895113 · Cardiotronics, Inc. · Oct 1989