Cleared Traditional

PROPAQ ECG TELEMETRY OPTION (K934711) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934711 · Protocol Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
335d
Days
Class 2
Risk

K934711 is an FDA 510(k) clearance for the PROPAQ ECG TELEMETRY OPTION. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Protocol Systems, Inc. (Beaverton, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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. Elevated predicate reliance profile. 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 Protocol Systems, Inc. devices

Submission Details

510(k) Number K934711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date September 01, 1994
Days to Decision 335 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 125d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 58
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K934711.
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
K946175 · Nihon Kohden America, Inc. · Nov 1995
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
K945578 · Nihon Kohden America, Inc. · Nov 1995
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037 · Siemens Medical Solutions USA, Inc. · Mar 1995
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239 · Nihon Kohden America, Inc. · Jun 1986
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302 · Quinton, Inc. · May 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376 · Hewlett-Packard Co. · Jan 1985