Cleared Traditional

K142969 - ANI Monitor

K142969 is an FDA 510(k) clearance for ANI Monitor, manufactured by Mdoloris Medical Systems Sas. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K142969 · Mdoloris Medical Systems Sas · Cardiovascular device
Download Printable Device Report (PDF)
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Feb 2016
Decision
497d
Days
Class 2
Risk

K142969 is an FDA 510(k) clearance for the ANI Monitor. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mdoloris Medical Systems Sas (Lille, FR). The FDA issued a Cleared decision on February 23, 2016 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Mdoloris Medical Systems Sas devices

FDA 510(k) Submission Details - K142969

510(k) Number K142969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2014
Decision Date February 23, 2016
Days to Decision 497 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
372d slower than avg
Panel avg: 125d · This submission: 497d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 306
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K142969.
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