Cleared Traditional

K843533 - CARDIAC EVENT RECORDER

K843533 is the FDA 510(k) clearance for CARDIAC EVENT RECORDER by Cryo2 Corp.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K843533 · Cryo2 Corp. · Cardiovascular device
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Jun 1985
Decision
294d
Days
Class 2
Risk

K843533 is an FDA 510(k) clearance for the CARDIAC EVENT RECORDER. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Cryo2 Corp. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 294 days - an extended review cycle.

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 Cryo2 Corp. devices

Submission Details

510(k) Number K843533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date June 28, 1985
Days to Decision 294 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 125d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K843533.
PATIENT MONITOR PB240
K853318 · Puritan Bennett Corp. · Mar 1986
SIRECUST 341 AND 341R
K854881 · Siemens Medical Solutions USA, Inc. · Mar 1986
VSM MODELS A & B
K851916 · Physio-Control Corp. · Aug 1985
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187 · Siemens Medical Solutions USA, Inc. · Apr 1985
PATIENT MONITOR 78354A
K842236 · Hewlett-Packard Co. · Jan 1985