# K161704: Phasor Drill

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Dec 1, 2016 after 164 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931783 (1993). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014060: Microaire 1000E System, Microaire Surgical Instruments, Inc. (2002) Summary page 4.
- K962913: Synthes Sterile Drill Bits, Synthes (Usa) (1996) Summary page 4.

## Most influential descendants
- K230619: Hubly Electric Drill (H100) (2023), 1 descendant of its own
- K252696: Legacy (2025), 0 descendants of its own
- K250815: Hubly Drill (H100) (2025), 0 descendants of its own
- K252060: GREEN (2025), 0 descendants of its own

## Recalls of this device
- Mar 21, 2025 · Class II · Z-2192-2025: Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

## Indications for use
The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

Source page: https://510kreport.com/device/K161704
Methodology: https://510kreport.com/methodology