510(k) · Cleared
Recalled · Class II · 2017Boehringer Mannheim/Hitachi 917 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Sep 25, 1995 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it. It has been recalled 18 times.
- Decided
- Sep 25, 1995
- Review
- 76 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 18
- Predicates
- 0
41 later devices descend from it, 5 citing it directly.
- This deviceK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995
- Descendant · cites it directly · 18 of its ownK060373 Cobas 6000 Series SystemRoche Diagnostics · 2006 · Recalled
- Descendant · 2 generations on · 9 of its ownK100853 Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · Recalled
- Descendant · cites it directly · 8 of its ownK041627 Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004
- Descendant · cites it directly · 7 of its ownK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · Recalled
- Descendant · 2 generations on · 5 of its ownK080811 Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C…Roche Diagnostics Corp. · 2008
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K060373Cobas 6000 Series SystemRoche Diagnostics · 2006 · cites it directly18descendants
- K100853Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · 2 generations on9descendants
- K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004 · cites it directly8descendants
- K990092Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · cites it directly7descendants
- K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Roche Diagnostics Corp. · 2008 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | — |
| +1 | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | 10 |
| +2 | K100853 | Cobas 8000 Modular Series Analyzer | Roche Diagnostics Corp. | 2010 | 11 |
| +1 | K041627 | Cystatin C Immunoparticles, Control Set, Calibrator | Dako A/S | 2004 | — |
| +1 | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | 4 |
| +2 | K080811 | Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin… | Roche Diagnostics Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (41)
See all 415 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2017 | Class II | Z-1269-2018 | Labeling False and Misleading | Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters. |
| Jun 29, 2017 | Class II | Z-0378-2018 | Software design | Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation. |
| Jul 15, 2016 | Class II | Z-0094-2017 | Device Design | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| May 7, 2015 | Class II | Z-1922-2015 | Under Investigation by firm | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only)… |
| Nov 12, 2008 | Not classified | Z-1067-2009 | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. |
| Nov 12, 2008 | Not classified | Z-1068-2009 | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. |
| Nov 12, 2008 | Not classified | Z-1065-2009 | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. |
| Nov 12, 2008 | Not classified | Z-1066-2009 | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. |
| Mar 21, 2008 | Not classified | Z-0870-2008 | Process change control | Possible mismatch between patient and result. |
| Mar 21, 2008 | Not classified | Z-0867-2008 | Process change control | Possible mismatch between patient and result. |
| Mar 21, 2008 | Not classified | Z-0869-2008 | Process change control | Possible mismatch between patient and result. |
| Mar 21, 2008 | Not classified | Z-0866-2008 | Process change control | Possible mismatch between patient and result. |
| Jul 21, 2006 | Not classified | Z-1447-06 | Other | Expired product (dated 2006.06) was shipped as replacement for recalled product. |
| Jul 14, 2006 | Not classified | Z-1352-06 | Other | A design change in the electrodes will result in incorrect potassium level results. |
| Aug 6, 2004 | Not classified | Z-1430-04 | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. |
| Aug 6, 2004 | Not classified | Z-1429-04 | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. |
| Aug 6, 2004 | Not classified | Z-1431-04 | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. |
| May 8, 2003 | Not classified | Z-0012-04 | Other | Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted. |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060373 (Roche Diagnostics, 2006) has gone furthest, with 18 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/K953239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953239: Boehringer Mannheim/Hitachi 917 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953239
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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