Cleared Traditional

280/4 MINI-DEFIBRILLATOR (K812520) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812520 · Life Science Instrumentation, Inc. · Cardiovascular device
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Sep 1981
Decision
23d
Days
Class 2
Risk

K812520 is an FDA 510(k) clearance for the 280/4 MINI-DEFIBRILLATOR. 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 September 25, 1981 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life Science Instrumentation, Inc. devices

Submission Details

510(k) Number K812520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1981
Decision Date September 25, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 21
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K812520.
TEC-3500 DEFIBRILLATOR
K840258 · Nihon Kohden America, Inc. · May 1984
THERACARD 400
K823828 · Siemens Medical Solutions USA, Inc. · Mar 1983
MODEL 78670A
K823268 · Hewlett-Packard Co. · Jan 1983
DEFIBRILLATOR/MONITOR
K812317 · Hewlett-Packard Co. · Sep 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · Datascope Corp. · Jul 1981