Cleared Traditional

450SLL DEFIBRILLATOR (K874204) - FDA 510(k) Clearance

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

K874204 · Medical Research Laboratories, Inc. · Cardiovascular device
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Jan 1988
Decision
105d
Days
Class 2
Risk

K874204 is an FDA 510(k) clearance for the 450SLL DEFIBRILLATOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Medical Research Laboratories, Inc. (Niles, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 105 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 Medical Research Laboratories, Inc. devices

Submission Details

510(k) Number K874204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date January 28, 1988
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K874204.
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575 · Nihon Kohden America, Inc. · Aug 1988
CARDIOLIFE TEC 7100
K863404 · Nihon Kohden America, Inc. · Oct 1986
CARDIOLIFE TEC 7200
K863405 · Nihon Kohden America, Inc. · Oct 1986
MODEL 617D
K863303 · Quinton, Inc. · Sep 1986