Cleared Traditional

K242001 - Philips VSC-MEDlib (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K242001 · Philips Medical Systems Nederland B.V. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
269d
Days
Class 2
Risk

K242001 is an FDA 510(k) clearance for the Philips VSC-MEDlib. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Eindhoven, NL). The FDA issued a Cleared decision on April 4, 2025 after a review of 269 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K242001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2024
Decision Date April 04, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 139d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06140433 Completed Interventional Industry-sponsored

Vital Signs Camera Study

94
Patients (actual)
1
Site
Screening
Purpose
Open label
Masking
Condition studied Respiration Rate; Heart Rate
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Murk Westerterp
Sponsor Philips Clinical & Medical Affairs Global (industry)
Started 2024-02-02 → Primary completion 2024-03-15
Primary outcome
Clinical safety and effectiveness VSC-MEDlib according to IFU
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 173
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K242001.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · Linshom Medical, Inc. · Sep 2025
Respiree Cardio- Respiratory Monitor System
K250934 · Respiree Pte, Ltd. · Aug 2025
RTMsense Respiratory Monitoring System
K243183 · Rtm Vital Signs, LLC · Jun 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966 · Faceheart Corp. · Apr 2025
Makani Science™ Respiration Monitoring System
K233953 · Makani Science, Inc. · Mar 2025
Airmod
K242798 · Heroic Faith International , Ltd. · Feb 2025