Cleared Abbreviated

K133989 - AMBULO 2400 AMBULATORY BLOOD PRESSURE M...

K133989 is the FDA 510(k) clearance for AMBULO 2400 AMBULATORY BLOOD PRESSURE M... by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 334-day FDA review.

K133989 · Mortara Instrument, Inc. · Cardiovascular device
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Nov 2014
Decision
334d
Days
Class 2
Risk

K133989 is an FDA 510(k) clearance for the AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mortara Instrument, Inc. devices

Submission Details

510(k) Number K133989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date November 25, 2014
Days to Decision 334 days
Submission Type Abbreviated
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
209d slower than avg
Panel avg: 125d · This submission: 334d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 492
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