Cleared Traditional

K832724 - ACTIMETER UB-103

K832724 is the FDA 510(k) clearance for ACTIMETER UB-103 by Copal, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K832724 · Copal, Inc. · Cardiovascular device
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Dec 1983
Decision
132d
Days
Class 2
Risk

K832724 is an FDA 510(k) clearance for the ACTIMETER UB-103. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Copal, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 132 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 Copal, Inc. devices

Submission Details

510(k) Number K832724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date December 22, 1983
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
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 155
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K832724.
SEVOMED COMPACT MONITOR SMK 154-
K832095 · Litton Medical Electronics · Mar 1984
PATIENT MONITOR 78534B
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TREND PROCESSOR OPTION FOR #515 NEONAT
K833552 · Ge Medical Systems Information Technologies · Jan 1984
PATIENT MONITOR CM 135
K831164 · Honeywell, Inc. · Dec 1983
SERVOMED COMPACT MONITOR SMK 154-8/101
K832021 · Litton Medical Electronics · Nov 1983
SERVOMED COMPACT MONITOR SMK 155-9
K832035 · Litton Medical Electronics · Nov 1983