Cleared Traditional

K991211 - EVENTSTATION ECG TRANS-TELEPHONIC RECEI...

K991211 is the FDA 510(k) clearance for EVENTSTATION ECG TRANS-TELEPHONIC RECEI... by Reynolds Medical , Ltd.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991211 · Reynolds Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
90d
Days
Class 2
Risk

K991211 is an FDA 510(k) clearance for the EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Reynolds Medical , Ltd. (Hertford, GB). The FDA issued a Cleared decision on July 8, 1999 after a review of 90 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 Reynolds Medical , Ltd. devices

Submission Details

510(k) Number K991211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1999
Decision Date July 08, 1999
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 110
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K991211.
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TELEMEDICINE 2000
K991307 · Card Guard Scientific Survival , Ltd. · Jun 1999
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K983026 · Card Guard Scientific Survival , Ltd. · Dec 1998
SENTINEL RECORDER, MODELS 471/472
K971696 · Del Mar Avionics · Dec 1997