# K250093: Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

- Pathway: 510(k) (Traditional)
- Applicant: Linshom Medical, Inc.
- Decided: Sep 26, 2025 after 255 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: 25 generations back to K941811 (1994). 151 ancestors in all.
No later device cites it as a predicate yet.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240271: Linshom Continuous Predictive Respiratory Monitoring System (CPRMS), Linshom Medical, Inc. (2024) Summary page 5.

## Indications for use
Linshom Continuous Predictive Respiratory Monitor System (CPRMS) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult, (at least 22 years of age) patients. The CPRMS is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume. CPRMS measurements are used as an adjunct to other clinical information sources.

Source page: https://510kreport.com/device/K250093
Methodology: https://510kreport.com/methodology