Cleared Traditional

K854491 - ERG 550 ERGOMETER BICYCLE

K854491 is an FDA 510(k) clearance for ERG 550 ERGOMETER BICYCLE, 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 216-day FDA review.

K854491 · Robert Bosch Corp. · Cardiovascular device
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Jun 1986
Decision
216d
Days
Class 2
Risk

K854491 is an FDA 510(k) clearance for the ERG 550 ERGOMETER BICYCLE. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Robert Bosch Corp. (St. James, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 216 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 Robert Bosch Corp. devices

FDA 510(k) Submission Details - K854491

510(k) Number K854491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date June 16, 1986
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
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 217
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K854491.
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · Advantage Medical Systems, Inc. · Dec 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986
LIFE-WATCH MONITOR LT-8
K863534 · Computerized Medical Systems, Inc. · Nov 1986
ERG 551 ERGOMETER, BICYCLE
K854492 · Robert Bosch Corp. · Jun 1986
ERG 555 COUCH ERGOMETER
K854493 · Robert Bosch Corp. · Jun 1986
CARDIOCAP MONITOR
K853953 · Instrumentarium Corp. · Jun 1986