510(k) · Cleared
ClearedHitachi 717 Chemistry 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 Jul 9, 1987 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jul 9, 1987
- Review
- 15 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 5 citing it directly.
- This deviceK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- Descendant · cites it directly · 7 of its ownK980367 Aeroset SystemAbbott Laboratories · 1998 · Recalled
- Descendant · 2 generations on · 3 of its ownK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK213486 GLP systems TrackAbbott Laboratories · 2022
- Descendant · 2 generations on · 1 of its ownK170320 Alinity c ICT Sample DiluentAbbott Laboratories · 2017
- Descendant · 2 generations on · 1 of its ownK170316 Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K980367Aeroset SystemAbbott Laboratories · 1998 · cites it directly7descendants
- K093318Accelerator ApsAbbott Laboratories · 2010 · 2 generations on3descendants
- K213486GLP systems TrackAbbott Laboratories · 2022 · 3 generations on1descendant
- K170320Alinity c ICT Sample DiluentAbbott Laboratories · 2017 · 2 generations on1descendant
- K170316Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| +1 | K980367 | Aeroset System | Abbott Laboratories | 1998 | 34 |
| +2 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| +3 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
| +2 | K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | 2017 | — |
| +2 | K170316 | Alinity C Glucose Reagent Kit, Alinity C System | Abbott Laboratories | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (12)
See all 125 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, K980367 (Abbott Laboratories, 1998) has gone furthest, with 7 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/K872494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K872494: Hitachi 717 Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872494
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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