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.
View all Mortara Instrument, Inc. devices
NCT02642198
Unknown
Observational
Industry-sponsored
Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects
Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old
| Condition studied |
Non-invasive Blood Pressure |
| Eligibility |
All sexes
· 29 Days+
· Healthy volunteers accepted
|
| Sponsor |
Mortara Instrument
(industry)
|
Started 2015-10-01
Primary completion 2016-03-01
Primary outcome
To study is the non-invasive blood pressure measurements accuracy validation performed with the Surveyor S12 / S19 monitor in pediatric, infants and children up to 3 years patients per ISO 81060-2: 2013 requirements.
View full study on ClinicalTrials.gov