Cleared Traditional

K884804 - THE COACH

K884804 is an FDA 510(k) clearance for THE COACH, manufactured by Promark, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K884804 · Promark, Inc. · Cardiovascular device
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May 1989
Decision
183d
Days
Class 2
Risk

K884804 is an FDA 510(k) clearance for the THE COACH. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Promark, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 19, 1989 after a review of 183 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Promark, Inc. devices

FDA 510(k) Submission Details - K884804

510(k) Number K884804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date May 19, 1989
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 227
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K884804.
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · S & W Medico Teknik · Oct 1989
HORIZON CENTRAL STATION
K892066 · Mennen Medical, Inc. · Jun 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · Healthdyne, Inc. · May 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · S & W Medico Teknik · Apr 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · Ivy Biomedical Systems, Inc. · Mar 1989
PATIENT MONITOR MODEL 701
K884096 · Ivy Biomedical Systems, Inc. · Feb 1989