Cleared Traditional

K840587 - INSTANT REPLAY

K840587 is an FDA 510(k) clearance for INSTANT REPLAY, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K840587 · Instromedix, Inc. · Cardiovascular device
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Oct 1984
Decision
261d
Days
Class 2
Risk

K840587 is an FDA 510(k) clearance for the INSTANT REPLAY. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Instromedix, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 26, 1984 after a review of 261 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 Instromedix, Inc. devices

FDA 510(k) Submission Details - K840587

510(k) Number K840587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date October 26, 1984
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
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 113
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K840587.
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716 · Medical Data Electronics · Feb 1985
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · Hewlett-Packard Co. · Dec 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