Cleared Traditional

K851931 - DEFI 2

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

K851931 · S & W Medico Teknik · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K851931

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
Combination Product No
PCCP Authorized No
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.

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 107
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K851931.
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
FC-700 DEFIBRILLATOR
K850618 · Fukuda Denshi USA, Inc. · Apr 1985
PORTABLE DEFIBRILLATOR/MONITOR ED 425
K851092 · Honeywell, Inc. · Apr 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · Hewlett-Packard Co. · Feb 1985