Cleared Traditional

K823931 - DEFIGARD M(OR DEFISCOPE M

K823931 is an FDA 510(k) clearance for DEFIGARD M(OR DEFISCOPE M, manufactured by Odam. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K823931 · Odam · Cardiovascular device
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Apr 1983
Decision
104d
Days
Class 2
Risk

K823931 is an FDA 510(k) clearance for the DEFIGARD M(OR DEFISCOPE M. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Odam (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 104 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 - K823931

510(k) Number K823931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1982
Decision Date April 12, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K823931.
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696 · Honeywell, Inc. · Nov 1983
VPD540 DEFIBRILLATOR
K822617 · Life Science Instrumentation, Inc. · Apr 1983
DEFIBRILLATOR VPD 545
K831056 · Life Science Instrumentation, Inc. · Apr 1983
THERACARD 400
K823828 · Siemens Medical Solutions USA, Inc. · Mar 1983
MODEL 78670A
K823268 · Hewlett-Packard Co. · Jan 1983
PORTA FIB III
K822961 · Narco Scientific · Nov 1982