Cleared Traditional

K182637 - Philips IntelliVue XDS Software

K182637 is an FDA 510(k) clearance for Philips IntelliVue XDS Software, manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K182637 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
214d
Days
Class 2
Risk

K182637 is an FDA 510(k) clearance for the Philips IntelliVue XDS Software. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on April 26, 2019 after a review of 214 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

FDA 510(k) Submission Details - K182637

510(k) Number K182637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date April 26, 2019
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 106
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