# K252060: GREEN

- Pathway: 510(k) (Traditional)
- Applicant: Phasor Health, LLC
- Decided: Oct 31, 2025 after 122 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931783 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161704: Phasor Drill, Biotex, Inc. (2016) Summary page 5.

## Indications for use
Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone.

Source page: https://510kreport.com/device/K252060
Methodology: https://510kreport.com/methodology