510(k) · Cleared
ClearedUrotract I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America, Inc. · KQS Table, Cystometric, Non-Electric And Accessories
Cleared on Dec 6, 1995 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 6, 1995
- Review
- 34 days
- Class
- Class I
- Product code
- KQS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK955019 Urotract IDornier Medtech America, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK122768 GenesisDornier Medtech America, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133434 Genesis IIDornier Medtech America, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK151485 GenesisDornier Medtech America, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK220871 NautilusDornier Medtech America, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK130729 Extra Corporeal Shockwave LithotripterDornier Medtech Systems · 2013
Most influential descendants
Showing 5 of 5 · See all- K122768GenesisDornier Medtech America, Inc. · 2013 · cites it directly4descendants
- K133434Genesis IIDornier Medtech America, Inc. · 2014 · cites it directly2descendants
- K151485GenesisDornier Medtech America, Inc. · 2015 · 2 generations on1descendant
- K220871NautilusDornier Medtech America, Inc. · 2022 · 3 generations on0descendants
- K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955019 | Urotract I | Dornier Medtech America, Inc. | 1995 | — |
| +1 | K122768 | Genesis | Dornier Medtech America, Inc. | 2013 | — |
| +1 | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +2 | K151485 | Genesis | Dornier Medtech America, Inc. | 2015 | — |
| +3 | K220871 | Nautilus | Dornier Medtech America, Inc. | 2022 | — |
| +2 | K130729 | Extra Corporeal Shockwave Lithotripter | Dornier Medtech Systems | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KQS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K122768 (Dornier Medtech America, Inc., 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KQS devicesKQS Table, Cystometric, Non-Electric And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQS
FDA has decided no KQS device since 2007.
Median 510(k) review, days · KQS
Too few KQS 510(k)s in any year since 2007 to give a median.
Recalls per year · KQS
No recall names KQS since 2007.
Adverse event reports per year · KQS
1in 2022
MAUDE reports naming product code KQS, 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 | 2 |
| 2008 | 0 | — | 0 | 138 |
| 2009 | 0 | — | 0 | 178 |
| 2010 | 0 | — | 0 | 106 |
| 2011 | 0 | — | 0 | 172 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955019: Urotract I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955019
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026