510(k) · Cleared
ClearedRoche Cobas Mira Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Apr 29, 1992 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- Apr 29, 1992
- Review
- 89 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK920402 Roche Cobas Mira PlusRoche Diagnostic Systems, Inc. · 1992
- Descendant · cites it directly · 15 of its ownK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
- Descendant · 2 generations on · 1 of its ownK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK110137 Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2011 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · cites it directly15descendants
- K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · 2 generations on3descendants
- K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · 2 generations on2descendants
- K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas · 2012 · 2 generations on1descendant
- K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920402 | Roche Cobas Mira Plus | Roche Diagnostic Systems, Inc. | 1992 | — |
| +1 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| +2 | K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | 2006 | 2 |
| +2 | K123171 | Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical… | Horiba Abx Sas | 2013 | — |
| +2 | K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx… | Horiba Abx Sas | 2012 | 3 |
| +2 | K110137 | Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control… | Horiba Abx Sas | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 JJE? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 182 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, K052007 (Horiba Abx, 2005) has gone furthest, with 15 descendants of its own.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
https://510kreport.com/device/K920402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920402: Roche Cobas Mira Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920402
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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