Cleared Traditional

K853673 - CARDIORATER CR 51

K853673 is an FDA 510(k) clearance for CARDIORATER CR 51, manufactured by Cardiac Recorders, Ltd.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K853673 · Cardiac Recorders, Ltd. · Cardiovascular device
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Dec 1985
Decision
98d
Days
Class 2
Risk

K853673 is an FDA 510(k) clearance for the CARDIORATER CR 51. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Cardiac Recorders, Ltd. (London, GB). The FDA issued a Cleared decision on December 11, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

FDA 510(k) Submission Details - K853673

510(k) Number K853673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date December 11, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 228
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K853673.
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125 · Honeywell, Inc. · Mar 1986
PATIENT MONITOR PB240
K853318 · Puritan Bennett Corp. · Mar 1986
SIRECUST 341 AND 341R
K854881 · Siemens Medical Solutions USA, Inc. · Mar 1986
ECS 502
K840717 · Robert Bosch Corp. · Aug 1985
VSM MODELS A & B
K851916 · Physio-Control Corp. · Aug 1985
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985