Cleared Traditional

K850114 - C/PES 9201, ECG STRESS TESTING SYS

K850114 is an FDA 510(k) clearance for C/PES 9201, manufactured by Gould, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K850114

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
Combination Product No
PCCP Authorized No
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.

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 202
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K850114.
KONTRON MINIMON 7132 PATIENT MONITOR
K844732 · Kontron Instruments, Inc. · Mar 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · Kontron Instruments, Inc. · Mar 1985
LS 5
K842037 · Life Science Instrumentation, Inc. · Mar 1985
CARDIOGUARD STRESS TEST MONITOR 4002
K850043 · Del Mar Avionics · Feb 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
K850113 · Gould, Inc. · Feb 1985
SPACELABS SERIES 600 PATIENT MONITORS
K844888 · Spacelabs, Inc. · Feb 1985