Class Class II
Enlight 2100 (K222897)
Description
Enlight 2100 by Timpel S.A., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222897
Clearance Date2023-03-07
Clearance TypeTraditional
Product CodeQEB
Regulation Number868.1505
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222897
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. Enlight 2100 (K222897) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023 |
| K211135 | Enlight 2100 | Timpel S.A. | 2022 |
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | 2011 |
Trace the full predicate network for K222897
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.