Cleared Traditional

RHYTHMSTAT XL (K971650) - FDA 510(k) Clearance

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

K971650 · Data Critical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
212d
Days
Class 2
Risk

K971650 is an FDA 510(k) clearance for the RHYTHMSTAT XL. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Data Critical Corp. (Houston, US). The FDA issued a Cleared decision on December 4, 1997 after a review of 212 days - an extended review cycle.

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 Data Critical Corp. devices

Submission Details

510(k) Number K971650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date December 04, 1997
Days to Decision 212 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
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K971650.
FibriCheck
K173872 · Qompium NV · Sep 2018
CARDIOSKIN
K173248 · Bioserenity Sas · Aug 2018
QT ECG
K180157 · QT Medical, Inc. · May 2018
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
K915769 · Medtronic Vascular · Jan 1992
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
K913533 · Hewlett-Packard Co. · Nov 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · Medtronic Vascular · Jul 1991