510(k) · Cleared
ClearedSmartClip Delivery Catheter (ADR-1715)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elucent Medical · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on May 14, 2026 as substantially equivalent to K142934 (Covidien, 2015) after an 84-day review. Its family tree reaches back 4 generations to 1993. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- May 14, 2026
- Review
- 84 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931154 (1993). 6 ancestors in all, the oldest K914181 (1991). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 3 generations backK060243 Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK131234 Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013
- 1 generation backK142934 CrossCountry Transbronchial Access Tool straight, CrossCountry…Covidien · 2015
- This deviceK260565 SmartClip Delivery Catheter (ADR-1715)Elucent Medical · 2026
Class I recalls in this family
- K060243 Olympus Guide Sheath, Model XBO1-836-133 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −3 | K060243 | Olympus Guide Sheath, Model XBO1-836-13 | Olympus Medical Systems Corporation | 2006 | Class I |
| −2 | K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) | Broncus Medical, Inc. | 2013 | — |
| −1 | K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial… | Covidien | 2015 | — |
| 0 (this device) | K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Summary page 5…Rigid) Classification Name: Bronchoscope (flexible or rigid) and accessories Regulation Number: 21 CFR 874.4680 Product Codes: EOQ Legally Marketed Predicate Device: K142934 – CrossCountry Transbronchial Access Tool - EOQ Device Description Summary: The Catheter Delivery System is a single-use, termi… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 10.9 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K142934.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
SmartClip Delivery Catheter is to be utilized through a flexible bronchoscope by physicians trained in endoscopic techniques to puncture the tracheobronchial wall and to facilitate the delivery and placement of an Elucent SmartClip soft tissue marker within the lung parenchyma at a target site. The device is used in situations where the lung tissue site needs to be marked for future diagnostic or therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260565: SmartClip Delivery Catheter (ADR-1715).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260565
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026