510(k) · Cleared
ClearedTBAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Sep 20, 1996 as substantially equivalent to K914181 (Mill-Rose Laboratory, 1991) after a 32-day review. Its family tree reaches back 1 generation to 1991. 19 later devices descend from it.
- Decided
- Sep 20, 1996
- Review
- 32 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914181 (1991). 19 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- This deviceK963252 TBANBoston Scientific Corp · 1996
- Descendant · cites it directly · 17 of its ownK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
- Descendant · 2 generations on · 15 of its ownK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
- Descendant · 3 generations on · 14 of its ownK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
- Descendant · 4 generations on · 12 of its ownK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- Descendant · 5 generations on · 5 of its ownK202370 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K040018Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004 · cites it directly17descendants
- K142839GenCut Core Biopsy SystemCovidien, LLC · 2015 · 2 generations on15descendants
- K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017 · 3 generations on14descendants
- K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · 4 generations on12descendants
- K202370Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| 0 (this device) | K963252 | TBAN | Boston Scientific Corp | 1996 | — |
| +1 | K040018 | Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 | Boston Scientific Corp | 2004 | — |
| +2 | K142839 | GenCut Core Biopsy System | Covidien, LLC | 2015 | — |
| +3 | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | 2017 | — |
| +4 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| +5 | K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K840033 | FDA’s K840033 is Hypodermic Needles & Stylets Our OCR of the scanned summary read K840033, FDA’s number for Hypodermic Needles & Stylets (Microvasive). Its FDA name has none of the distinctive words the summary uses for the device it names, “Boston Scientific's TBAN”. Kept off the family tree. Summary page 3…OSE’S TRANSBRONCHIAL ASPIRATION NEEDLE Modified Boston Mill-Rose’s Transbronchial Scientific’'s TBAN | Transbronchial Aspiration Needle Aspiration Needle (This 510(k)) (K840033) (K914181) - USE Indication Aspiration in carinal, hilar, paratracheal, Aspriati Aspiration for and peripheral spnation cytology/… | 1984 |
| * | K914181 | Wang/Mill-Rose Transbronchial Aspiration NeedleSummary page 3…SBRONCHIAL ASPIRATION NEEDLE Modified Boston Mill-Rose’s Transbronchial Scientific’'s TBAN | Transbronchial Aspiration Needle Aspiration Needle (This 510(k)) (K840033) (K914181) - USE Indication Aspiration in carinal, hilar, paratracheal, Aspriati Aspiration for and peripheral spnation cytology/histology… | 1991 |
What descends from it? (19)
See all 193 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?
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Transbronchial Aspiration Needle is indicated for use in aspiration in carinal, paratracheal, hilar, and peripheral lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
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/K963252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963252: TBAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963252
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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