# K213228: NeuroLine Disposable Cranial Perforator with Hudson end

- Pathway: 510(k) (Traditional)
- Applicant: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
- Decided: Jun 20, 2022 after 264 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K833266 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833266: Acra-Cut, Acra Cut, Inc. (1983) Summary page 4.

## Indications for use
NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.

Source page: https://510kreport.com/device/K213228
Methodology: https://510kreport.com/methodology