Cleared Traditional

K861621 - CARDIAN II CR45A

K861621 is an FDA 510(k) clearance for CARDIAN II CR45A, 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 136-day FDA review.

K861621 · Cardiac Recorders, Ltd. · Cardiovascular device
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Sep 1986
Decision
136d
Days
Class 2
Risk

K861621 is an FDA 510(k) clearance for the CARDIAN II CR45A. 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 September 12, 1986 after a review of 136 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 - K861621

510(k) Number K861621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date September 12, 1986
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
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 K861621.
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · Advantage Medical Systems, Inc. · Dec 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986
LIFE-WATCH MONITOR LT-8
K863534 · Computerized Medical Systems, Inc. · Nov 1986
ERG 550 ERGOMETER BICYCLE
K854491 · Robert Bosch Corp. · Jun 1986
ERG 551 ERGOMETER, BICYCLE
K854492 · Robert Bosch Corp. · Jun 1986
ERG 555 COUCH ERGOMETER
K854493 · Robert Bosch Corp. · Jun 1986