Cleared Traditional

K991910 - LIFEPAK 12 BIPHASIC

K991910 is an FDA 510(k) clearance for LIFEPAK 12 BIPHASIC, manufactured by Physio-Control Corp.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K991910 · Physio-Control Corp. · Cardiovascular device
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Sep 1999
Decision
88d
Days
Class 3
Risk

K991910 is an FDA 510(k) clearance for the LIFEPAK 12 BIPHASIC. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K991910

510(k) Number K991910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 07, 1999
Decision Date September 03, 1999
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

MKJ Device Classification - Class 3, Premarket Approval

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
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.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 118
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K991910.
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · Hewlett-Packard Co. · Dec 1999
ZOLL M SERIES 12SL ANALYSIS OPTION
K991556 · Zoll Medical Corp · Oct 1999
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K990762 · Zoll Medical Corp · Sep 1999
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
K991007 · Katecho, Inc. · Aug 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871 · Hewlett-Packard Co. · Aug 1999
LIFEPAK 500 BIPHASIC
K983393 · Physio-Control Corp. · May 1999