Cleared Traditional

K831092 - PECGASYS REMOTE TRANSMISSION UNIT

K831092 is an FDA 510(k) clearance for PECGASYS REMOTE TRANSMISSION UNIT, manufactured by Datamedix. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K831092 · Datamedix · Cardiovascular device
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Jul 1983
Decision
106d
Days
Class 2
Risk

K831092 is an FDA 510(k) clearance for the PECGASYS REMOTE TRANSMISSION UNIT. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Datamedix (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Datamedix devices

FDA 510(k) Submission Details - K831092

510(k) Number K831092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date July 19, 1983
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 204
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K831092.
INSTANT REPLAY
K840587 · Instromedix, Inc. · Oct 1984
MODEM ACCESSORY FOR EPI CARDIA SYS
K834034 · Medicomp, Inc. · May 1984
PACELINE PATIENT TRANSMITTER MODEL 324
K831443 · Pacesetter Systems · Aug 1983
CARDIOMEMO III
K830477 · Instromedix, Inc. · May 1983
SIRECUST 456
K830028 · Analogic Corp. · Jan 1983
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · Medtronic Vascular · Nov 1982