# K252528: Ion Endoluminal System (IF1000)

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 5, 2025 after 25 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™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater. The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

Source page: https://510kreport.com/device/K252528
Methodology: https://510kreport.com/methodology