Cleared Traditional

CR 280/45, CR281/4 DEFIBRILLATOR (K852905) - FDA 510(k) Clearance

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

K852905 · Cardiac Recorders, Ltd. · Cardiovascular device
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Nov 1985
Decision
119d
Days
Class 2
Risk

K852905 is an FDA 510(k) clearance for the CR 280/45, CR281/4 DEFIBRILLATOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Cardiac Recorders, Ltd. (London, GB). The FDA issued a Cleared decision on November 5, 1985 after a review of 119 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 Cardiac Recorders, Ltd. devices

Submission Details

510(k) Number K852905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date November 05, 1985
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
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 K852905.
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
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