Cleared Traditional

K850114 - C/PES 9201

K850114 is the FDA 510(k) clearance for C/PES 9201 by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K850114 · Gould, Inc. · Cardiovascular device
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Feb 1985
Decision
39d
Days
Class 2
Risk

K850114 is an FDA 510(k) clearance for the C/PES 9201, ECG STRESS TESTING SYS. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Gould, Inc. (Dayton, US). The FDA issued a Cleared decision on February 22, 1985 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gould, Inc. devices

Submission Details

510(k) Number K850114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 22, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
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 K850114.
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
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · Nihon Kohden America, Inc. · Jan 1985
DYNASCOPE MONITOR DS-800
K844348 · Fukuda Denshi USA, Inc. · Dec 1984