# K230619: Hubly Electric Drill (H100)

- Pathway: 510(k) (Traditional)
- Applicant: Hubly, Inc.
- Decided: May 4, 2023 after 59 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.
1 later device descends from it; 1 cites it directly.
0 of 17 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 4.

## Most influential descendants
- K250815: Hubly Drill (H100) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K230619
Methodology: https://510kreport.com/methodology