# K243945: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Apr 24, 2025 after 125 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: 13 generations back to K950697 (1995). 128 ancestors in all.
No later device cites it as a predicate yet.
1 of 129 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit), SurGenTec, LLC (2024) Summary page 5.
- K190163: ALARA Neuro Access Kit, SurGenTec, LLC (2019) Summary page 5.
- K131157: Ranfac Bone Marrow Aspiration Needle, Ranfac, Corp. (2013) Summary page 5.

## 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. The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.

Source page: https://510kreport.com/device/K243945
Methodology: https://510kreport.com/methodology