# K991625: Komet XK-95 Perforator Motor (MI-102)

- Pathway: 510(k) (Traditional)
- Applicant: Komet Medical
- Decided: Jul 30, 1999 after 80 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013091: ZMM 2000 Zeppelin Millennium Motordrill System (2002), 6 descendants of its own
- K130755: Hicut Highspeed Instrument (2014), 4 descendants of its own
- K232684: Surgify Halo (2023), 3 descendants of its own
- K250380: Surgify Halo   (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (2025), 2 descendants of its own
- K251433: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (2025), 1 descendant of its own

## Indications for use
The XK-95 Perforator Motor is intended to be used in conjunction with various cranial perforators with a Hudson adapter for cranial perforations.

Source page: https://510kreport.com/device/K991625
Methodology: https://510kreport.com/methodology