510(k) · Cleared
Recalled · Class II · 2025Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
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 Aug 26, 2021 as substantially equivalent to K201146 (Intuitive Surgical, Inc., 2020) after a 57-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 26, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K914181 (1991). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- 7 generations backK963252 TBANBoston Scientific Corp · 1996
- 6 generations backK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
- 5 generations backK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
- 4 generations backK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
- 3 generations backK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- 2 generations backK192367 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019
- 1 generation backK201146 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
- This deviceK212048 Ion Endoluminal System (Ion Fully Articulating Catheter), Ion…Intuitive Surgical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240135 Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)Intuitive Surgical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)Intuitive Surgical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| −7 | K963252 | TBAN | Boston Scientific Corp | 1996 | — |
| −6 | K040018 | Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 | Boston Scientific Corp | 2004 | — |
| −5 | K142839 | GenCut Core Biopsy System | Covidien, LLC | 2015 | — |
| −4 | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | 2017 | — |
| −3 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| −2 | K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2019 | — |
| −1 | K201146 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
| 0 (this device) | K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal… | Intuitive Surgical, Inc. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K201146 | 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 (K201146), cleared on June 26, 2020. 4. Device Description The Ion™ Endoluminal System (Model IF1000) is a software-controlled,… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240135 | Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2025 | Class II | Z-1134-2026 | Process control | Due to probe bags that may have a compromised or incomplete sterile pouch seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K240135 (Intuitive Surgical, Inc., 2024) has gone furthest, with 0 descendants 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. 2021, 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/K212048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212048: Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212048
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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