510(k) · Cleared
ClearedIon Endoluminal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jun 26, 2020 as substantially equivalent to K192367 (Intuitive Surgical, Inc., 2019) after a 58-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- Jun 26, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914181 (1991). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- 6 generations backK963252 TBANBoston Scientific Corp · 1996
- 5 generations backK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
- 4 generations backK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
- 3 generations backK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
- 2 generations backK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- 1 generation backK192367 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019
- This deviceK201146 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK212048 Ion Endoluminal System (Ion Fully Articulating Catheter), Ion…Intuitive Surgical, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK240135 Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)Intuitive Surgical, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| −6 | K963252 | TBAN | Boston Scientific Corp | 1996 | — |
| −5 | K040018 | Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 | Boston Scientific Corp | 2004 | — |
| −4 | K142839 | GenCut Core Biopsy System | Covidien, LLC | 2015 | — |
| −3 | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | 2017 | — |
| −2 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| −1 | K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2019 | — |
| 0 (this device) | K201146 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
| +1 | K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal… | Intuitive Surgical, Inc. | 2021 | 1 |
| +2 | K240135 | Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EOQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192367 | Ion Endoluminal SystemSummary page 4…EOQ Review Panel: Ear, Nose, and Throat 3. Predicate Device The predicate device for this submission is the Ion™ Endoluminal System (K192367), cleared on November 26, 2019. 4. Device Description The Ion™ Endoluminal System (Model IF1000) is a software-control… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion… | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K212048 (Intuitive Surgical, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
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 and is not for pediatric use.
The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201146 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201146: Ion Endoluminal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201146
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026