510(k) · Cleared
ClearedDimension (R) XL Clinical Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.I. Dupont DE Nemours & Co., Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Nov 10, 1994 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Nov 10, 1994
- Review
- 80 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK944093 Dimension (R) XL Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1994
- Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK060266 Dimension Iron CalibratorDade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK060264 Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 2006 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
- K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 2 generations on1descendant
- K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · 2 generations on1descendant
- K060266Dimension Iron CalibratorDade Behring, Inc. · 2006 · cites it directly1descendant
- K060264Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944093 | Dimension (R) XL Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1994 | — |
| +1 | K051087 | Dimension Vista Integrated System | Dade Behring, Inc. | 2005 | 32 |
| +2 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| +2 | K061838 | Dimension Vista Chemistry 1 Calibrator, Model KC110 | Dade Behring, Inc. | 2006 | 3 |
| +1 | K060266 | Dimension Iron Calibrator | Dade Behring, Inc. | 2006 | 1 |
| +1 | K060264 | Dimension Iron Flex Reagent Cartridge (Iron-DF85) | Dade Behring, Inc. | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 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? (10)
4 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, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 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/K944093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944093: Dimension (R) XL Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944093
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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