510(k) · Cleared
ClearedFlexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opcom Medical, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on May 28, 2025 as substantially equivalent to K231878 (STERIS Corporation, 2023) after a 261-day review. Its family tree reaches back 11 generations to 1993. 1 of the 29 devices in its family, counting itself, has a Class I recall.
- Decided
- May 28, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931154 (1993). 28 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK211347 Uretero1 Ureteroscope SystemSTERIS Corporation · 2021
- 2 generations backK223466 Uretero1 Single-Use Digital Flexible Ureteroscope (standard…STERIS Corporation · 2023
- 1 generation backK231878 Uretero1 Single-Use Digital Flexible Ureteroscope (standard…STERIS Corporation · 2023
- This deviceK242699 Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US)…Opcom Medical, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 7 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 6 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 5 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 4 generations backK153049 LithoVue SystemBoston Scientific Corporation · 2015
- 3 generations backK211347 Uretero1 Ureteroscope SystemSTERIS Corporation · 2021
- 2 generations backK223466 Uretero1 Single-Use Digital Flexible Ureteroscope (standard…STERIS Corporation · 2023
- 1 generation backK231878 Uretero1 Single-Use Digital Flexible Ureteroscope (standard…STERIS Corporation · 2023
- This deviceK242699 Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US)…Opcom Medical, Inc. · 2025
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope9 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −7 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −6 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −5 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −4 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| −3 | K211347 | Uretero1 Ureteroscope System | STERIS Corporation | 2021 | — |
| −2 | K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN… | STERIS Corporation | 2023 | — |
| −1 | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN… | STERIS Corporation | 2023 | — |
| 0 (this device) | K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible… | Opcom Medical, Inc. | 2025 | — |
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 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…Summary page 5…6. Classification Name Ureteroscope And Accessories, Flexible/Rigid 7. Regulation Number 876.1500 8. Product Code FGB, FET 9. Predicate Device K231878: Uretero1™ Ureteroscope System, STERIS Corporation 10. Reference Device K221158: Single-Use Video Flexible Ureterorenoscope… | 2023 |
| † | K221158 | Single-Use Video Flexible Ureterorenoscope System | 2023 |
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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 9 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 28 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, this device’s year, is highlighted.
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 Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary…
Read the full statement (100 words)
The Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary tract.
Images Systems (Camera-Controlled Unit) is intended to provide power to and receive, process, display, and output recordings of images from compatible visualization devices, the intended medical indication will be defined by the connected visualization devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242699: Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242699
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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