# K140088: Phantom XL Insulated Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Tedan Surgical Innovations, LLC
- Decided: Sep 25, 2014 after 254 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K980148 (1998). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110419: Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators, Stryker Spine (2011) Summary page 4.

## Most influential descendants
- K231691: Phantom XL Insulated Dilators (2023), 1 descendant of its own
- K253580: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (2026), 0 descendants of its own

## Indications for use
Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.

Source page: https://510kreport.com/device/K140088
Methodology: https://510kreport.com/methodology