# K002828: XPS Nitro System

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Oct 17, 2000 after 36 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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.

## Recalls of this device
- Jul 17, 2009 · Not classified · Z-0259-2010: An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.

Source page: https://510kreport.com/device/K002828
Methodology: https://510kreport.com/methodology