# K002224: XPS 3000 System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed
- Decided: Dec 4, 2000 after 133 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
465 later devices descend from it; 3 cite it directly.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041523: XPS 3000 System (2004), 459 descendants of its own
- K041413: XPS 3000 System (2004), 453 descendants of its own
- K073255: XPS 3000 System (2008), 448 descendants of its own
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), 443 descendants of its own
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) (2008), 420 descendants of its own

Source page: https://510kreport.com/device/K002224
Methodology: https://510kreport.com/methodology