# K252045: Ion Endoluminal System (IF1000)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 23, 2025 after 85 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K914181 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242070: Ion Endoluminal System (IF 1000), Intuitive Surgical, Inc. (2024) Summary page 5.

## Indications for use
The Ion ™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion TM Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. The Plan Point ™ Software uses patient CT scans to create a 30 plan of the lung and navigation pathways for use with the Ion TM Endoluminal System.

Source page: https://510kreport.com/device/K252045
Methodology: https://510kreport.com/methodology