510(k) · Cleared
ClearedLungVision Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodyvision Medical, Ltd. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Apr 26, 2018 as substantially equivalent to K060243 (Olympus Medical Systems Corporation, 2006) after a 212-day review. Its family tree reaches back 2 generations to 1993. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 26, 2018
- Review
- 212 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931154 (1993). 1 later device descends from it, 1 citing it directly. 1 of the 4 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 deviceK172955 LungVision ToolBodyvision Medical, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK221302 Recon Steerable SheathSerpex Medical, Inc. · 2022
Class I recalls in this family
- K060243 Olympus Guide Sheath, Model XBO1-836-13direct predicate · 2006
Most influential descendants
Showing 1 of 1 · See all- K221302Recon Steerable SheathSerpex Medical, Inc. · 2022 · 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) | K172955 | LungVision Tool | Bodyvision Medical, Ltd. | 2018 | — |
| +1 | K221302 | Recon Steerable Sheath | Serpex Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K060243 | Olympus Guide Sheath, Model XBO1-836-13Summary page 4…sification Name: Bronchoscope (flexible or rigid) and accessories EOQ, Class II, CFR 874.4680 Predicate Device: K060243 - Olympus Sheath Guide Reference Device: K151315 - Boston Scientific Expect™ Pulmonary Endobronchial… | 2006 |
| † | K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | 2015 |
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 |
|---|---|---|---|
| K221302 | Recon Steerable Sheath | 2022 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K221302 (Serpex Medical, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K060243.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes,
endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area,
specifically within the respiratory system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172955: LungVision Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172955
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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