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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Speed TO Market, Inc.
THOMAS KROENKE

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 - DPS Electrocardiograph

All 475
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K142969.
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