510(k) · Cleared
ClearedMipron/Umipron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kontron Electronics · LLZ System, Image Processing, Radiological
Cleared on Oct 27, 1989 after a 219-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 902 devices in its family, counting itself, have a Class I recall. 901 later devices descend from it.
- Decided
- Oct 27, 1989
- Review
- 219 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
901 later devices descend from it, 2 citing it directly. 2 of the 902 devices in this family, counting this one, have a Class I recall.
- This deviceK891689 Mipron/UmipronKontron Electronics · 1989
- Descendant · cites it directly · 899 of its ownK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- Descendant · 2 generations on · 898 of its ownK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- Descendant · 3 generations on · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 4 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 5 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
Showing 5 of 901 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 901 · See all- K982800Ecton Lynx Ultrasound SystemEcton, Inc. · 1998 · cites it directly899descendants
- K021497Cypress Ultrasound SystemAcuson Corp. · 2002 · 2 generations on898descendants
- K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on827descendants
- K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on806descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 5 generations on802descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891689 | Mipron/Umipron | Kontron Electronics | 1989 | — |
| +1 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| +2 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| +3 | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +4 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +5 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 10 | 0 |
| 2011 | 22 | 0 |
| 2012 | 29 | 0 |
| 2013 | 38 | 0 |
| 2014 | 51 | 0 |
| 2015 | 53 | 0 |
| 2016 | 63 | 0 |
| 2017 | 74 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 72 | 0 |
| 2021 | 51 | 0 |
| 2022 | 59 | 0 |
| 2023 | 54 | 0 |
| 2024 | 57 | 0 |
| 2025 | 75 | 2 |
| 2026 | 51 | 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.
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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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? (901)
See all 9012 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.
What does this lineage say?
- Of its descendants, K982800 (Ecton, Inc., 1998) has gone furthest, with 899 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
https://510kreport.com/device/K891689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K891689: Mipron/Umipron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891689
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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