# K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Aug 9, 2024 after 154 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K950697 (1995). 127 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 129 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131157: Ranfac Bone Marrow Aspiration Needle, Ranfac, Corp. (2013) Summary page 4.
- K190163: ALARA Neuro Access Kit, SurGenTec, LLC (2019) Summary page 4.

## Most influential descendants
- K243945: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (2025), 0 descendants of its own

## Indications for use
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood. The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

Source page: https://510kreport.com/device/K240664
Methodology: https://510kreport.com/methodology