510(k) · Cleared
Recalled · Class II · 2024Ion Endoluminal System ; Flexision Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Feb 14, 2019 as substantially equivalent to K141366 (Scholly Fiberoptic GmbH, 2014) and 1 other predicate after a 185-day review. Its family tree reaches back 5 generations to 1991. 12 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 14, 2019
- Review
- 185 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914181 (1991). 7 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- 4 generations backK963252 TBANBoston Scientific Corp · 1996
- 3 generations backK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
- 2 generations backK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
- 1 generation backK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
- This deviceK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019
- Descendant · cites it directly · 5 of its ownK202370 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK220299 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK232984 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK192367 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK242070 Ion Endoluminal System (IF 1000)Intuitive Surgical, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K202370Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020 · cites it directly5descendants
- K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022 · 2 generations on4descendants
- K232984Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2023 · 3 generations on3descendants
- K192367Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019 · cites it directly3descendants
- K242070Ion Endoluminal System (IF 1000)Intuitive Surgical, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| −4 | K963252 | TBAN | Boston Scientific Corp | 1996 | — |
| −3 | K040018 | Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 | Boston Scientific Corp | 2004 | — |
| −2 | K142839 | GenCut Core Biopsy System | Covidien, LLC | 2015 | — |
| −1 | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | 2017 | — |
| 0 (this device) | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | — |
| +1 | K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
| +2 | K220299 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2022 | — |
| +3 | K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2023 | — |
| +1 | K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2019 | — |
| +4 | K242070 | Ion Endoluminal System (IF 1000) | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K141366 | Video Bronchoscope SystemSummary page 4…ible or rigid) and accessories Product Codes: EOQ Advisory Committee: Ear, Nose, and Throat Predicate Devices: Schoelly Video Bronchoscope (K141366) Trade Name: Flexision™ Biopsy Needle Common Name: Bronchoscope (flexible or rigid) and accessor… | 2014 |
| * | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaSummary page 4…exible or rigid) and accessories Product Codes: EOQ Advisory Committee: Ear, Nose, and Throat Predicate Devices: Arcpoint Pulmonary Needle (K163537) In compliance with FDA Guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]… | 2017 |
| † | K173760 | Monarch Endoscopy Platform (Monarch Platform) | 2018 |
| † | K173244 | superDimension Navigation System V7.2 | 2018 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2024 | Class II | Z-2720-2024 | Under Investigation by firm | There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways. |
| Aug 6, 2021 | Class II | Z-0106-2022 | Under Investigation by firm | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. |
| Oct 23, 2020 | Class II | Z-0489-2021 | Device Design | The distal tip ring of the fully articulating catheter may become dislodged during the procedure. |
| Jun 10, 2020 | Class II | Z-2950-2020 | Device Design | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during… |
| Jun 10, 2020 | Class II | Z-2949-2020 | Device Design | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K202370 (Intuitive Surgical, Inc., 2020) has gone furthest, with 5 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. 2019, 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/K182188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182188: Ion Endoluminal System ; Flexision Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182188
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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