Cleared Traditional

K884126 - E-RAM

K884126 is the FDA 510(k) clearance for E-RAM by Reynolds Medical , Ltd.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K884126 · Reynolds Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
395d
Days
Class 2
Risk

K884126 is an FDA 510(k) clearance for the E-RAM. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Reynolds Medical , Ltd. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Reynolds Medical , Ltd. devices

Submission Details

510(k) Number K884126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date October 30, 1989
Days to Decision 395 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 125d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 75
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K884126.
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · Mennen Medical, Inc. · Aug 1991
PR4
K911097 · Mortara Instrument, Inc. · Aug 1991
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · Del Mar Avionics · Feb 1990
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · Oxford Medilog, Inc. · Mar 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · Del Mar Avionics · Jan 1989
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · Del Mar Avionics · Nov 1988