# K250815: Hubly Drill (H100)

- Pathway: 510(k) (Traditional)
- Applicant: Hubly, Inc.
- Decided: Nov 6, 2025 after 234 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: 8 generations back to K931783 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230619: Hubly Electric Drill (H100), Hubly, Inc. (2023) Summary page 5.

## Indications for use
The Hubly Auto-Stop Drill (H100) is a single-use, sterile, disposable device intended for use on adult patients during laminectomy and laminotomy procedures for drilling holes through the lamina.

Source page: https://510kreport.com/device/K250815
Methodology: https://510kreport.com/methodology