Cleared Traditional

K212208 - Philips IntelliVue GuardianSoftware (Rev. E.0X) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212208 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Sep 2021
Decision
77d
Days
Class 2
Risk

K212208 is an FDA 510(k) clearance for the Philips IntelliVue GuardianSoftware (Rev. E.0X). Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on September 30, 2021 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medizin Systeme Boeblingen GmbH devices

Submission Details

510(k) Number K212208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2021
Decision Date September 30, 2021
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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

Regulatory Technology Services, LLC
Prithul Bom

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.