Cleared Traditional

K081140 - VISENSIA

K081140 is an FDA 510(k) clearance for VISENSIA, manufactured by Obs Medical. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K081140 · Obs Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
86d
Days
Class 2
Risk

K081140 is an FDA 510(k) clearance for the VISENSIA. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Obs Medical (Carmel, US). The FDA issued a Cleared decision on July 17, 2008 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Obs Medical devices

FDA 510(k) Submission Details - K081140

510(k) Number K081140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2008
Decision Date July 17, 2008
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 352
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