510(k) · Cleared
ClearedUsa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Jan 3, 2003 as substantially equivalent to K012951 (Circon Video, 2001) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1997. 1 of the 106 devices in its family, counting itself, has a Class I recall. 101 later devices descend from it.
- Decided
- Jan 3, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K971977 (1997). 4 ancestors in all. 101 later devices descend from it, 2 citing it directly. 1 of the 106 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK971977 Ksea 15.5 FR. Flexible Choledocho-FiberscopeKARL STORZ Endoscopy-America, Inc. · 1997
- This deviceK023358 Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8Acmi Corporation · 2003
- Descendant · cites it directly · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- Descendant · 2 generations on · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 24 of its ownK153049 LithoVue SystemBoston Scientific Corporation · 2015
- Descendant · 3 generations on · 23 of its ownK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 23 of its ownK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor4 generations on · 2024
Most influential descendants
Showing 5 of 101 · See all- K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006 · cites it directly99descendants
- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · 2 generations on53descendants
- K153049LithoVue SystemBoston Scientific Corporation · 2015 · 2 generations on24descendants
- K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017 · 3 generations on23descendants
- K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971977 | Ksea 15.5 FR. Flexible Choledocho-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 1997 | — |
| 0 (this device) | K023358 | Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8 | Acmi Corporation | 2003 | — |
| +1 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| +2 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +2 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| +3 | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| +2 | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 18 | 1 |
| 2025 | 18 | 0 |
| 2026 | 13 | 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K012951 | Apn-2 Usa Series Flexible Choledochoscope | 2001 |
| * | K972926 | MVM 7.5 French Flexible CholedochoscopeSummary page 1…Classification Name: Endoscope and accessories 3. Predicate Devices ACMI APNTM-2(KO 12951) 0 Karl Storz MVM 7.5 Fr. Flexible Choledochoscope (K972926:) 0 Karl Storz 15.5 Fr. Flexible Choledocho-Fiberscope (K97 1977) ACMI DURTM-8(KO 12925) 4. Device Description… | 1997 |
| * | K971977 | Ksea 15.5 FR. Flexible Choledocho-FiberscopeSummary page 1…Devices ACMI APNTM-2(KO 12951) 0 Karl Storz MVM 7.5 Fr. Flexible Choledochoscope (K972926:) 0 Karl Storz 15.5 Fr. Flexible Choledocho-Fiberscope (K97 1977) ACMI DURTM-8(KO 12925) 4. Device Description Both the DURTM-8and DURTM-8Eare non-sterile, reusable flexible fi… | 1997 |
| * | K012925 | Dur-8, Models Dur-8 | 2001 |
What descends from it? (101)
See all 1012 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.
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The ACMI USA Series™ DUR-8 and DUR-8Elite (DUR-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR-8 and DUR-8E are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023358: Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023358
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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