Cleared Traditional

PATIENT MONITOR CM 135 (K831164) - FDA 510(k) Clearance

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

K831164 · Honeywell, Inc. · Cardiovascular device
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Dec 1983
Decision
234d
Days
Class 2
Risk

K831164 is an FDA 510(k) clearance for the PATIENT MONITOR CM 135. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Honeywell, Inc. (Walker, US). The FDA issued a Cleared decision on December 1, 1983 after a review of 234 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 Honeywell, Inc. devices

Submission Details

510(k) Number K831164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1983
Decision Date December 01, 1983
Days to Decision 234 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 125d · This submission: 234d
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 68
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K831164.
LIFESCOPE 6 OEC-6105
K841502 · Nihon Kohden America, Inc. · Aug 1984
PATIENT MONITOR 78534B
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TREND PROCESSOR OPTION FOR #515 NEONAT
K833552 · Ge Medical Systems Information Technologies · Jan 1984
PATIENT MONITOR 788 33A
K831943 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78832A
K831944 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78353A
K831787 · Hewlett-Packard Co. · Sep 1983