Cleared Traditional

K832724 - ACTIMETER UB-103

K832724 is an FDA 510(k) clearance for ACTIMETER UB-103, manufactured by Copal, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K832724

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.

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 223
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
K840251 · Hewlett-Packard Co. · Feb 1984
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