510(k) · Cleared
ClearedEcn Electronic Video Cystonephroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Jul 16, 2003 as substantially equivalent to K904797 (Surgitek, 1991) and 4 other predicates after a 111-day review. Its family tree reaches back 4 generations to 1993. 2 of the 119 devices in its family, counting itself, have a Class I recall. 103 later devices descend from it.
- Decided
- Jul 16, 2003
- Review
- 111 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K931154 (1993). 15 ancestors in all, the oldest K843084 (1985). 103 later devices descend from it, 2 citing it directly. 2 of the 119 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 3 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 2 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 1 generation backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- This deviceK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- Descendant · cites it directly · 101 of its ownK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- Descendant · 2 generations on · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- Descendant · 3 generations on · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 24 of its ownK153049 LithoVue SystemBoston Scientific Corporation · 2015
- Descendant · 4 generations on · 23 of its ownK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 103 · See all- K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004 · cites it directly101descendants
- K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006 · 2 generations on99descendants
- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · 3 generations on53descendants
- K153049LithoVue SystemBoston Scientific Corporation · 2015 · 3 generations on24descendants
- K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017 · 4 generations on23descendants
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 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −2 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| 0 (this device) | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +1 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| +2 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| +3 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +3 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| +4 | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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.
2 devices in this family have 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K904797 | Surgitek Graduated Cystoscope (Model GC-16)Summary page 2…izes the flexible endoscope technology (design and materials) of the following ACMI flexible endoscopes: = ACMI USA Seriesm ACN-2 Flexible CystoNephroswpe (K904797) = ACMI USA Seriesm AI" -2 Flexiile Choledochoscope (K012951) The ECN Flexible Video Cystonephroscope incorporate… | 1991 |
| * | K012951 | Apn-2 Usa Series Flexible CholedochoscopeSummary page 2…he following ACMI flexible endoscopes: = ACMI USA Seriesm ACN-2 Flexible CystoNephroswpe (K904797) = ACMI USA Seriesm AI" -2 Flexiile Choledochoscope (K012951) The ECN Flexible Video Cystonephroscope incorporatesthe video sensor technology located in the distal tip of the endo… | 2001 |
| * | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VASummary page 2…gy located in the distal tip of the endoscope similar to that utilized in the following devices: = Wra CystovldeoscopeCYF Type VffA, Olympw America, Inc., (K021074) = Pentax ECY-1530Video Choledoconephroscope, Pentax America, (pbably wvered under K95 1191 and mtemal letter… | 2002 |
| * | K951191 | FCN-15X, Fiber CholedochonephroscopeSummary page 2…= Wra CystovldeoscopeCYF Type VffA, Olympw America, Inc., (K021074) = Pentax ECY-1530Video Choledoconephroscope, Pentax America, (pbably wvered under K95 1191 and mtemal letter to file adding video) The ECN Flexible Video Cystonephmscope incorporates the CMOS sensor techology simil… | 1995 |
| * | K010489 | Dyonics Vision 111 Mobile Video Unit | 2001 |
What descends from it? (103)
See all 1032 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K042225 (Acmi Corporation, 2004) has gone furthest, with 101 descendants of its own.
- 1 other device also cites its predicate K904797.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030960: Ecn Electronic Video Cystonephroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030960
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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