Class Class II
Chlorine Sentinel II (K243898)
Description
Chlorine Sentinel II by Nelson Environmental Technologies, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243898
Clearance Date2025-04-11
Clearance TypeTraditional
Product CodeMSY
Regulation Number876.5665
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243898
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. Chlorine Sentinel II (K243898) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, ... | 2020 |
Trace the full predicate network for K243898
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.