Cleared Traditional

K854117 - AMENDMENT LIFEPAK 8

K854117 is an FDA 510(k) clearance for AMENDMENT LIFEPAK 8, manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K854117 · Physio-Control Corp. · Cardiovascular device
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Jan 1986
Decision
96d
Days
Class 2
Risk

K854117 is an FDA 510(k) clearance for the AMENDMENT LIFEPAK 8, NPN 052. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 - K854117

510(k) Number K854117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1985
Decision Date January 13, 1986
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 40
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K854117.
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547 · Medtronic Vascular · Oct 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · Medtronic Vascular · Jul 1986
AMI CARDIO-PAD
K860283 · Andover Medical, Inc. · Mar 1986
LIFEPAK 8 MODIFICATION
K853732 · Physio-Control Corp. · Dec 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812 · Life Science Instrumentation, Inc. · Nov 1985
PACEPAC
K852958 · Medical Data Electronics · Oct 1985