510(k) · Cleared
ClearedMaxiflex - Semi Flex Scope, 25 to 65 CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technology Delivery Systems, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Apr 4, 2012 as substantially equivalent to K062725 (Technology Delivery Systems, Inc., 2006) and 1 other predicate after a 313-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Apr 4, 2012
- Review
- 313 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971977 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK971977 Ksea 15.5 FR. Flexible Choledocho-FiberscopeKARL STORZ Endoscopy-America, Inc. · 1997
- 1 generation backK023358 Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8Acmi Corporation · 2003
- This deviceK111480 Maxiflex - Semi Flex Scope, 25 to 65 CMTechnology Delivery Systems, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971977 | Ksea 15.5 FR. Flexible Choledocho-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 1997 | — |
| −1 | K023358 | Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8 | Acmi Corporation | 2003 | — |
| 0 (this device) | K111480 | Maxiflex - Semi Flex Scope, 25 to 65 CM | Technology Delivery Systems, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 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.
Planning a device in FGB? 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? (2)
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 |
|---|---|---|---|
| * | K062725 | Maxiflex-Semi Flex ScopeSummary page 1…Device Class: Class 11 3. Predicate Devices: The Maxi-Flex Semi-Flex Scopes"' is substantially equivalent to the Maxi-Flex Semi-Flex Scopes [K062725] and ACMI DUR-8 [K023358]. 4. Indications for Use Statement: The MaxiFlex Semi Flex Scopes are intended to be us… | 2006 |
| * | K023358 | Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8Summary page 1…3. Predicate Devices: The Maxi-Flex Semi-Flex Scopes"' is substantially equivalent to the Maxi-Flex Semi-Flex Scopes [K062725] and ACMI DUR-8 [K023358]. 4. Indications for Use Statement: The MaxiFlex Semi Flex Scopes are intended to be used by trained medical… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 6 ancestors has a 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. 2012, 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 MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111480: Maxiflex - Semi Flex Scope, 25 to 65 CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111480
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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