# K242001: Philips VSC-MEDlib

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Apr 4, 2025 after 269 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913396 (1992). 49 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151940: Thora-3Di, Model T-01, Pneumacare Limited (2016) Summary page 5.

## Most influential descendants
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (2025), 1 descendant of its own
- K253650: Anura Mobile Core SDK (M1) (2026), 0 descendants of its own

## Indications for use
VitalSigns Camera Medical Library is a software library that can be integrated into a customer application for use during virtual consults or health screening. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner as a data point in the overall assessment of the patient. It is used under the supervision of a health care professional, either in the home or in a clinical environment when the subject is still and positioned properly in front of the camera (Samsung Galaxy A20e), which is placed on a stable surface in an adequately lit environment. It is intended to be used on patients aged 22 years and older that classify as ASA I (American Society of Anesthesiologists), which is defined as a normal healthy patient, non-smoking and no or minimal alcohol use. It is not intended for continuous patient monitoring system or as the sole method of checking the physical health of the patient, nor as an apnea monitor, but as a part of a framework which mandates periodic checks by a health care professional to ensure appropriate clinical diagnosis and treatment can be reached.

Source page: https://510kreport.com/device/K242001
Methodology: https://510kreport.com/methodology