Class Class II
RTMsense Respiratory Monitoring System (K243183)
Description
RTMsense Respiratory Monitoring System by Rtm Vital Signs, LLC, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243183
Clearance Date2025-06-27
Clearance TypeTraditional
Product CodeBZQ
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243183
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. RTMsense Respiratory Monitoring System (K243183) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242798 | Airmod | Heroic Faith International , Ltd. | 2025 |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | 2024 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024 |
| K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | Masimo Corporation | 2013 |
Trace the full predicate network for K243183
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.