Cleared Traditional

K854175 - DEFIGARD 2000

K854175 is an FDA 510(k) clearance for DEFIGARD 2000, manufactured by Odam. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K854175 · Odam · Cardiovascular device
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Jan 1986
Decision
90d
Days
Class 2
Risk

K854175 is an FDA 510(k) clearance for the DEFIGARD 2000. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Odam (Wissembourg Cedex, FR). The FDA issued a Cleared decision on January 13, 1986 after a review of 90 days - within the typical 510(k) review window.

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 Odam devices

FDA 510(k) Submission Details - K854175

510(k) Number K854175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date January 13, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 116
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K854175.
CARDIOLIFE TEC 7200
K863405 · Nihon Kohden America, Inc. · Oct 1986
MODEL 617D
K863303 · Quinton, Inc. · Sep 1986
DEFIB-PADS
K855082 · Conmedcorp · Mar 1986
KONTRON DEFIBRILLATOR 7501
K854307 · Kontron Instruments, Inc. · Dec 1985
MODEL 43130A DEFIBRILLATOR
K853439 · Hewlett-Packard Co. · Oct 1985
DEFI 502
K851485 · Robert Bosch Corp. · Aug 1985