Cleared Traditional

K840246 - MINI-DEFIBRILLATOR 280/4

K840246 is an FDA 510(k) clearance for MINI-DEFIBRILLATOR 280/4, manufactured by Life Science Instrumentation, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K840246 · Life Science Instrumentation, Inc. · Cardiovascular device
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Apr 1984
Decision
96d
Days
Class 2
Risk

K840246 is an FDA 510(k) clearance for the MINI-DEFIBRILLATOR 280/4. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Life Science Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 96 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 Life Science Instrumentation, Inc. devices

FDA 510(k) Submission Details - K840246

510(k) Number K840246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1984
Decision Date April 17, 1984
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
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 100
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K840246.
LIFEPAK 200
K843229 · Physio-Control Corp. · Oct 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667 · Marquette Electronics, Inc. · Aug 1984
TEC-3500 DEFIBRILLATOR
K840258 · Nihon Kohden America, Inc. · May 1984
PORTABLE DEFIBRILLATOR
K840167 · Honeywell, Inc. · Feb 1984
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696 · Honeywell, Inc. · Nov 1983
VPD540 DEFIBRILLATOR
K822617 · Life Science Instrumentation, Inc. · Apr 1983