510(k) · Cleared
ClearedLungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broncus Medical, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Oct 15, 2013 as substantially equivalent to K023337 (Boston Scientific Corp, 2002) and 1 other predicate after a 167-day review. Its family tree reaches back 2 generations to 1993. 1 of the 9 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 15, 2013
- Review
- 167 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931154 (1993). 3 ancestors in all. 5 later devices descend from it, 4 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 1 generation backK060243 Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · Recalled (Class I)
- This deviceK131234 Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK142934 CrossCountry Transbronchial Access Tool straight, CrossCountry…Covidien · 2015
- Descendant · 2 generations on · 0 of its ownK260565 SmartClip Delivery Catheter (ADR-1715)Elucent Medical · 2026
- Descendant · cites it directly · 0 of its ownK232601 BroncTru™ Transbronchial Access ToolBroncus Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK200702 EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK150280 PulmoVia Working ChannelSanovas, Inc. · 2015
Class I recalls in this family
- K060243 Olympus Guide Sheath, Model XBO1-836-13direct predicate · 2006
Most influential descendants
Showing 5 of 5 · See all- K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien · 2015 · cites it directly2descendants
- K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical · 2026 · 2 generations on0descendants
- K232601BroncTru™ Transbronchial Access ToolBroncus Medical, Inc. · 2024 · cites it directly0descendants
- K200702EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021 · cites it directly0descendants
- K150280PulmoVia Working ChannelSanovas, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −1 | K060243 | Olympus Guide Sheath, Model XBO1-836-13 | Olympus Medical Systems Corporation | 2006 | Class I |
| 0 (this device) | K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) | Broncus Medical, Inc. | 2013 | — |
| +1 | K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial… | Covidien | 2015 | — |
| +2 | K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | 2026 | — |
| +1 | K232601 | BroncTru™ Transbronchial Access Tool | Broncus Medical, Inc. | 2024 | — |
| +1 | K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | 2021 | — |
| +1 | K150280 | PulmoVia Working Channel | Sanovas, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320…Summary page 1…es identified are as follows: Trade Name - 510(k) Submitter-, 510(k) Numiber - CRE Pulmonary Balloon Boston Scientific K023337, cleared to market on Dilatation Catheter Corporation November 18, 2002 Olympus Guide Sheath… | 2002 |
| * | K060243 | Olympus Guide Sheath, Model XBO1-836-13Summary page 1…K023337, cleared to market on Dilatation Catheter Corporation November 18, 2002 Olympus Guide Sheath Olympus Medical K060243, cleared to market on Systems Corporation June 23, 2006 5. Device Description The LungPo… | 2006 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060243Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K142934 (Covidien, 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K023337.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 LungPoint Tools are endoscopic tools intended to be used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131234
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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