ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664)
Description
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) by SurGenTec, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240664
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. ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019 |
| K131157 | RANFAC BONE MARROW ASPIRATION NEEDLE | Ranfac, Corp. | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025 |
Trace the full predicate network for K240664
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.