510(k) · Cleared
ClearedHitachi 705 Automatic Blood Chemistry
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 May 27, 1981 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 27, 1981
- Review
- 27 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK811194 Hitachi 705 Automatic Blood ChemistryBoehringer Mannheim Corp. · 1981
- Descendant · cites it directly · 1 of its ownK981758 ALBGAbbott Laboratories · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK203248 Albumin BCG2Abbott Ireland Diagnostics Division · 2021
- Descendant · cites it directly · 0 of its ownK033060 Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK981791 MGAbbott Laboratories · 1998 · Recalled
- Descendant · cites it directly · 0 of its ownK981468 ALBGAbbott Laboratories · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K981758ALBGAbbott Laboratories · 1998 · cites it directly1descendant
- K203248Albumin BCG2Abbott Ireland Diagnostics Division · 2021 · 2 generations on0descendants
- K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004 · cites it directly0descendants
- K981791MGAbbott Laboratories · 1998 · cites it directly0descendants
- K981468ALBGAbbott Laboratories · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811194 | Hitachi 705 Automatic Blood Chemistry | Boehringer Mannheim Corp. | 1981 | — |
| +1 | K981758 | ALBG | Abbott Laboratories | 1998 | 1 |
| +2 | K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | 2021 | — |
| +1 | K033060 | Calibrating Material, Calibrating Standards | Diamond Diagnostics, Inc. | 2004 | — |
| +1 | K981791 | MG | Abbott Laboratories | 1998 | 1 |
| +1 | K981468 | ALBG | Abbott Laboratories | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 2004 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
5 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, K981758 (Abbott Laboratories, 1998) has gone furthest, with 1 descendant 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/K811194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811194: Hitachi 705 Automatic Blood Chemistry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811194
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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