Class Class II
FreeStyle Comfort (AS200 / FreeStyle Comfort) (K250671)
Description
FreeStyle Comfort (AS200 / FreeStyle Comfort) by Caire, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250671
Clearance Date2025-07-11
Clearance TypeTraditional
Product CodeCAW
Regulation Number868.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250671
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. FreeStyle Comfort (AS200 / FreeStyle Comfort) (K250671) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen | 2022 |
| K120785 | OMNI 3 OXYGEN SYSTEM | Caire, Inc. | 2012 |
Trace the full predicate network for K250671
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.