Class Class II
Respiree Cardio- Respiratory Monitor System (K250934)
Description
Respiree Cardio- Respiratory Monitor System by Respiree Pte, Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250934
Clearance Date2025-08-05
Clearance TypeTraditional
Product CodeBZQ
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250934
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Respiree Cardio- Respiratory Monitor System (K250934) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023 |
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | 2022 |
Trace the full predicate network for K250934
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.