Cleared Traditional

K911402 - MODEL #350 SHOCK-PLATE DEFIB ADAPTOR

K911402 is an FDA 510(k) clearance for MODEL #350 SHOCK-PLATE DEFIB ADAPTOR, manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K911402 · Cardiotronics, Inc. · Cardiovascular device
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Oct 1991
Decision
188d
Days
Class 2
Risk

K911402 is an FDA 510(k) clearance for the MODEL #350 SHOCK-PLATE DEFIB ADAPTOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on October 3, 1991 after a review of 188 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 Cardiotronics, Inc. devices

FDA 510(k) Submission Details - K911402

510(k) Number K911402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date October 03, 1991
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 81
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K911402.
MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
K911456 · Cardiotronics, Inc. · Oct 1991
MODEL #911 STEALTH MULTI PADS
K912621 · Cardiotronics, Inc. · Oct 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662 · Marquette Electronics, Inc. · Oct 1991
ESCORT 300 SERIES
K911665 · Medical Data Electronics · Aug 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · Physio-Control Corp. · Jul 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991