Class Class II
Respiree Cardio-Respiratory Monitor (K223681)
Description
Respiree Cardio-Respiratory Monitor by Respiree Pte, Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223681
Clearance Date2023-03-08
Clearance TypeTraditional
Product CodeBZQ
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223681
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 (K223681) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 |
| K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSO... | Philips Medizin Systeme Boeblingen ... | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 |
Trace the full predicate network for K223681
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.