Class Class II
Freespira Breathing System (K233337)
Description
Freespira Breathing System by Freespira, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233337
Clearance Date2025-04-24
Clearance TypeTraditional
Product CodeSEN
Regulation Number882.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233337
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. Freespira Breathing System (K233337) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018 |
| K131586 | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | 2013 |
Trace the full predicate network for K233337
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.