510(k) · Cleared
Recalled · Class II · 2017Elecsys 2010 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 Jun 14, 1996 after a 57-day review. The FDA summary names its predicate without a number. 32 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 14, 1996
- Review
- 57 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 6
- Predicates
- 0
32 later devices descend from it, 4 citing it directly.
- This deviceK961481 Elecsys 2010 AnalyzerBoehringer Mannheim Corp. · 1996
- 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 · 9 of its ownK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 3 of its ownK191899 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro…Roche Diagnostics · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K060373Cobas 6000 Series SystemRoche Diagnostics · 2006 · cites it directly18descendants
- K100853Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · 2 generations on9descendants
- K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006 · cites it directly9descendants
- K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics · 2019 · 2 generations on3descendants
- K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961481 | Elecsys 2010 Analyzer | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | 10 |
| +2 | K100853 | Cobas 8000 Modular Series Analyzer | Roche Diagnostics Corp. | 2010 | 11 |
| +1 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| +2 | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated… | Roche Diagnostics | 2019 | 3 |
| +2 | K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Boehringer Mannheim ES300 Immunoassay system Named without a submission number |
What descends from it? (32)
See all 324 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 |
|---|---|---|---|---|
| Jul 5, 2017 | Class II | Z-0499-2018 | Software design | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch. |
| Jul 15, 2016 | Class II | Z-0095-2017 | 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 21, 2014 | Class II | Z-1790-2014 | Labeling design | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. |
| Jan 31, 2012 | Not classified | Z-1218-2012 | Software design | Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results… |
| Jun 24, 2008 | Not classified | Z-0165-2009 | Other | A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly. |
| Mar 21, 2008 | Not classified | Z-0868-2008 | Process change control | Possible mismatch between patient and result. |
The 5 latest of 6 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 | — |
What is it indicated for?
The Elecsys 2010 analyzer is an immunoassay analyzer intended for the in vitro quantitative and qualitative determination of analytes in human serum and plasma
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961481: Elecsys 2010 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961481
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026