Cleared Traditional

K840717 - ECS 502

K840717 is an FDA 510(k) clearance for ECS 502, manufactured by Robert Bosch Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 549-day FDA review.

K840717 · Robert Bosch Corp. · Cardiovascular device
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Aug 1985
Decision
549d
Days
Class 2
Risk

K840717 is an FDA 510(k) clearance for the ECS 502. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Robert Bosch Corp. (Mchenry, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 549 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K840717

510(k) Number K840717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1984
Decision Date August 19, 1985
Days to Decision 549 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
424d slower than avg
Panel avg: 125d · This submission: 549d
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 340
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K840717.
CARDIORATER CR 51
K853673 · Cardiac Recorders, Ltd. · Dec 1985
CARDIORATER CR7
K852910 · Cardiac Recorders, Ltd. · Nov 1985
CR5 CARDIAC MONITOR
K852887 · Cardiac Recorders, Ltd. · Nov 1985
VSM MODELS A & B
K851916 · Physio-Control Corp. · Aug 1985
COACH TM- THE AEROBIC FITNESS MONITOR
K851335 · Biotechnology, Inc. · Jul 1985
CARDIAC EVENT RECORDER
K843533 · Cryo2 Corp. · Jun 1985
K840717 · ECS 502
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