Cleared Traditional

K170032 - QMAPP Amplifier

Also marketed or referenced as:
QMAPP Hemodynamic Monitoring System QMAPP PCM QMAPP GO QMAPP EP

K170032 is an FDA 510(k) clearance for QMAPP Amplifier, manufactured by Fysicon BV. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K170032 · Fysicon BV · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
247d
Days
Class 2
Risk

K170032 is an FDA 510(k) clearance for the QMAPP Amplifier. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Fysicon BV (Oss, NL). The FDA issued a Cleared decision on September 8, 2017 after a review of 247 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 Fysicon BV devices

FDA 510(k) Submission Details - K170032

510(k) Number K170032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2017
Decision Date September 08, 2017
Days to Decision 247 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 125d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

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 Consultant

Qserve Group, Us, Inc.
Patsy J. Trisler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 295
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K170032.
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All-in-One Health Monitor, PC-303
K170047 · Shenzhen Creative Industry Co., Ltd. · Sep 2017
Accutorr 7/VS-900 Vital Signs Monitor
K170712 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Aug 2017
Dictum Health
K170798 · Dictum Health, Inc. · Jul 2017
CoVa Monitoring System 2
K160899 · Tosense, Inc. · Jun 2017