510(k) · Cleared
ClearedArcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Apr 21, 2017 as substantially equivalent to K914181 (Mill-Rose Laboratory, 1991) and 1 other predicate after a 126-day review. Its family tree reaches back 4 generations to 1991. 14 later devices descend from it.
- Decided
- Apr 21, 2017
- Review
- 126 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914181 (1991). 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- 3 generations backK963252 TBANBoston Scientific Corp · 1996
- 2 generations backK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
- 1 generation backK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
- This deviceK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
- Descendant · cites it directly · 12 of its ownK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- Descendant · 2 generations on · 5 of its ownK202370 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK220299 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK232984 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK192367 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · cites it directly12descendants
- K202370Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020 · 2 generations on5descendants
- K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022 · 3 generations on4descendants
- K232984Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2023 · 4 generations on3descendants
- K192367Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| −3 | K963252 | TBAN | Boston Scientific Corp | 1996 | — |
| −2 | K040018 | Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 | Boston Scientific Corp | 2004 | — |
| −1 | K142839 | GenCut Core Biopsy System | Covidien, LLC | 2015 | — |
| 0 (this device) | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | 2017 | — |
| +1 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| +2 | K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
| +3 | K220299 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2022 | — |
| +4 | K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2023 | — |
| +2 | K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K914181 | Wang/Mill-Rose Transbronchial Aspiration NeedleSummary page 5…Product code: EOQ 3. Predicate Device Primary Predicate Device Device Name : Wang Transbronchial Aspriation Needle 510(k): K914181 Classification Name: Bronchoscope (flexible or rigid) and accessories 21 CFR Part 874.4680 Pr… | 1991 |
| * | K142839 | GenCut Core Biopsy SystemSummary page 5…de: EOQ Manufacturer: ConMed Corporation Secondary Predicate Device Device Name : GenCut™ Core Biopsy Tool 510(k): K142839 Classification Name: Bronchoscope (flexible or rigid) and accessories 21 CFR Part 874.4680 Pr… | 2015 |
What descends from it? (14)
See all 142 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)
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 26 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K182188 (Intuitive Surgical, 2019) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K914181.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Arcpoint™ pulmonary needle is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163537: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163537
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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