Cleared Traditional

K161517 - Mortara Surveyor Patient Monitor (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161517 · Mortara Instrument, Inc. · Cardiovascular device
Jan 2017
Decision
223d
Days
Class 2
Risk

K161517 is an FDA 510(k) clearance for the Mortara Surveyor Patient Monitor. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 11, 2017 after a review of 223 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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.

Submission Details

510(k) Number K161517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date January 11, 2017
Days to Decision 223 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 140d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 34
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K161517.
IntelliVue Multi-Measurement Module X3 (867030)
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Corvair Monza
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Multi-parameter Patient Monitor (N10)
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IntelliVue Patient Monitor MX750
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · Philips Medizin Systeme Boeblingen GmbH · Oct 2025
IntelliVue Patient Monitor 6100 (6100)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025