Philips VSC-MEDlib
by Philips Medical Systems Nederland B.V.
510(k) K242001
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242001 | Date4 Apr 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BZQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Philips VSC-MEDlib is a Monitor, Breathing Frequency device, classified under product code BZQ. It is designed to measure and display respiratory parameters, including breathing frequency, for clinical monitoring purposes in anesthesia and critical care settings.
This device is intended for use in regulated medical environments, such as operating rooms and intensive care units. It operates as a reusable, non-sterile medical instrument and has been cleared through the FDA’s Traditional 510(k) pathway as substantially equivalent to a predicate device. The Philips VSC-MEDlib adheres to regulatory standards outlined in 26 CFR 868.2375 and is manufactured by Philips Medical Systems Nederland B.V.
Other devices from Philips Medical Systems Nederland B.V.
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Questions
AI-generated answers, 18 Sep 2026
What clinical environments is the Philips VSC-MEDlib intended for use in, and why is this important for clinicians?
The Philips VSC-MEDlib is designed specifically for regulated medical environments such as operating rooms and intensive care units. This focus ensures it meets the rigorous monitoring needs of anesthesia and critical care settings, where precise respiratory parameter tracking—like breathing frequency—is critical for patient safety and clinical decision-making.
Is the Philips VSC-MEDlib reusable or single-use, and how does this affect its maintenance and cost considerations?
The Philips VSC-MEDlib is a reusable, non-sterile medical instrument. This design allows for cost-effective use over time, as it can be cleaned and reused across multiple patients, reducing disposal costs. However, it requires proper maintenance and cleaning protocols to ensure reliability and hygiene in clinical settings.
How was the regulatory pathway for the Philips VSC-MEDlib determined, and what does this mean for its approval status?
The Philips VSC-MEDlib was cleared through the FDA’s Traditional 510(k) pathway, specifically under the Substantially Equivalent (SESE) decision, after being reviewed by the Anesthesiology (AN) Advisory Committee. This means it was deemed equivalent to a predicate device already on the market, confirming its compliance with regulatory standards (26 CFR 868.2375) without requiring a full de novo review.
What types of respiratory parameters does the Philips VSC-MEDlib measure, and why is this relevant for anesthesia and critical care?
The Philips VSC-MEDlib is designed to measure and display breathing frequency, a key respiratory parameter critical for monitoring patients under anesthesia or in critical care. Accurate tracking of breathing frequency helps clinicians assess respiratory status, detect early signs of respiratory distress, and adjust ventilation or sedation as needed, improving patient outcomes.