Cleared Traditional

K851931 - DEFI 2

K851931 is the FDA 510(k) clearance for DEFI 2 by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851931 · S & W Medico Teknik · Cardiovascular device
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Aug 1985
Decision
95d
Days
Class 2
Risk

K851931 is an FDA 510(k) clearance for the DEFI 2. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by S & W Medico Teknik (Washington, US). The FDA issued a Cleared decision on August 5, 1985 after a review of 95 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 S & W Medico Teknik devices

Submission Details

510(k) Number K851931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1985
Decision Date August 05, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K851931.
MODEL 617D
K863303 · Quinton, Inc. · Sep 1986
DEFIB-PADS
K855082 · Conmedcorp · Mar 1986
MODEL 43130A DEFIBRILLATOR
K853439 · Hewlett-Packard Co. · Oct 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · Hewlett-Packard Co. · Feb 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447 · Datascope Corp. · Jan 1985
LIFEPAK 8
K842624 · Physio-Control Corp. · Oct 1984