# K253580: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

- Pathway: 510(k) (Traditional)
- Applicant: Tedan Surgical Innovations
- Decided: Apr 26, 2026 after 160 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: 8 generations back to K980148 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231691: Phantom XL Insulated Dilators, TeDan Surgical Innovations, Inc. (2023) Summary page 5.

## Indications for use
Spine surgery for sequential dilation and to deliver an electrical stimulation to the tissue and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure. Navigated ø5mm Insulated Dilator is intended to be used during spinal surgery to assist the surgeon in precisely establishing the desired access trajectory. Navigated ø5mm Insulated Dilator is specifically designed for use with Medtronic Stealth™ Systems, where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, or fluoroscopy images.

Source page: https://510kreport.com/device/K253580
Methodology: https://510kreport.com/methodology