Cleared Traditional

K051366 - PICONIBP OEM MODULE

K051366 is the FDA 510(k) clearance for PICONIBP OEM MODULE by Philips Medizin Systeme Boeblingen GmbH. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K051366 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Sep 2005
Decision
112d
Days
Class 2
Risk

K051366 is an FDA 510(k) clearance for the PICONIBP OEM MODULE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 14, 2005 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K051366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2005
Decision Date September 14, 2005
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 539
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