Cleared Traditional

K965117 - LIFE SUPPORT FOR TRAUMA AND TRANSPORT

K965117 is an FDA 510(k) clearance for LIFE SUPPORT FOR TRAUMA AND TRANSPORT, manufactured by Northrop Grumman Corp.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K965117 · Northrop Grumman Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
553d
Days
Class 3
Risk

K965117 is an FDA 510(k) clearance for the LIFE SUPPORT FOR TRAUMA AND TRANSPORT. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Northrop Grumman Corp. (Pico Rivera, US). The FDA issued a Cleared decision on June 26, 1998 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

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. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Northrop Grumman Corp. devices

FDA 510(k) Submission Details - K965117

510(k) Number K965117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 20, 1996
Decision Date June 26, 1998
Days to Decision 553 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
428d slower than avg
Panel avg: 125d · This submission: 553d
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 142
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K965117.
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
K983307 · Medical Research Laboratories, Inc. · Nov 1998
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K983287 · Graphic Controls Corp. · Nov 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR
K982025 · Hewlett-Packard Co. · Sep 1998
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
K980857 · Graphic Controls Corp. · May 1998
ZOLL REVIVER
K972241 · Zoll Medical Corp · Mar 1998
LIFE PAK 12
K973486 · Physio-Control Corp. · Jan 1998