Cleared Traditional

K170538 - RVS-100 Vital Signs Monitor

K170538 is the FDA 510(k) clearance for RVS-100 Vital Signs Monitor by Rudolf Riester GmbH. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K170538 · Rudolf Riester GmbH · Cardiovascular device
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Oct 2017
Decision
236d
Days
Class 2
Risk

K170538 is an FDA 510(k) clearance for the RVS-100 Vital Signs Monitor. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Rudolf Riester GmbH (Jungingen, DE). The FDA issued a Cleared decision on October 17, 2017 after a review of 236 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 Rudolf Riester GmbH devices

Submission Details

510(k) Number K170538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2017
Decision Date October 17, 2017
Days to Decision 236 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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