Class Class II
AF531 Oro-Nasal SE Face Mask (K243394)
Description
AF531 Oro-Nasal SE Face Mask by Respironics, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243394
Clearance Date2024-12-30
Clearance TypeTraditional
Product CodeCBK
Regulation Number868.5895
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243394
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. AF531 Oro-Nasal SE Face Mask (K243394) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015 |
| K101129 | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK | Respironics, Inc. | 2010 |
Trace the full predicate network for K243394
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.