Cleared Special

K012035 - BRAUN PRECISION SENSOR PRO

K012035 is the FDA 510(k) clearance for BRAUN PRECISION SENSOR PRO by Braun GmbH. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 28-day FDA review.

K012035 · Braun GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
28d
Days
Class 2
Risk

K012035 is an FDA 510(k) clearance for the BRAUN PRECISION SENSOR PRO, MODEL BP 2590. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Braun GmbH (Carlsbad, US). The FDA issued a Cleared decision on July 27, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Braun GmbH devices

Submission Details

510(k) Number K012035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date July 27, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 520
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K012035.
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K010828 · A&D Engineering, Inc. · Mar 2001