510(k) · Cleared
Recalled · Class II · 2012U04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 12, 2001 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled once.
- Decided
- Apr 12, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK010942 U04Siemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK122768 GenesisDornier Medtech America, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK161019 Uroview FDPausch Medical GmbH · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK133434 Genesis IIDornier Medtech America, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK173639 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K101491Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · cites it directly11descendants
- K122768GenesisDornier Medtech America, Inc. · 2013 · 2 generations on4descendants
- K161019Uroview FDPausch Medical GmbH · 2016 · 2 generations on2descendants
- K133434Genesis IIDornier Medtech America, Inc. · 2014 · 3 generations on2descendants
- K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010942 | U04 | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +1 | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | 12 |
| +2 | K122768 | Genesis | Dornier Medtech America, Inc. | 2013 | — |
| +2 | K161019 | Uroview FD | Pausch Medical GmbH | 2016 | 1 |
| +3 | K133434 | Genesis II | Dornier Medtech America, Inc. | 2014 | — |
| +2 | K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | Siemens Medi Cal Solutions, Inc. | 2018 | 23 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101491 | Uroskop Omnia | 2010 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2012 | Class II | Z-2341-2012 | Nonconforming Material/Component | Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101491 (Siemens Medical Solutions USA, Inc., 2010) has gone furthest, with 11 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
https://510kreport.com/device/K010942 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010942: U04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010942
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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