510(k) · Cleared
Recalled · Class II · 2018Dimension Clinical Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Nov 22, 2011 as substantially equivalent to K963498 (Dade Chemistry Systems, Inc., 1997) after a 46-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 7 times.
- Decided
- Nov 22, 2011
- Review
- 46 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963498 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963498 Ferr Flex Reagent CartridgeDade Chemistry Systems, Inc. · 1997 · Recalled
- This deviceK112999 Dimension Clinical Chemistry SystemSiemens Healthcare Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963498 | Ferr Flex Reagent Cartridge | Dade Chemistry Systems, Inc. | 1997 | 3 |
| 0 (this device) | K112999 | Dimension Clinical Chemistry System | Siemens Healthcare Diagnostics | 2011 | — |
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 |
|---|---|---|---|
| * | K963498 | Ferr Flex Reagent CartridgeSummary page 1…roduct Product Device 51 ~~ Class _______Code Dirrension®RxL/RxL DimensionS RxL/RxL Max K963498 1 862.2160 JJB Max clinical chemistry clinical chemistry analyzer analyzer… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2018 | Class II | Z-0409-2019 | Device Design | Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock |
| Jun 29, 2017 | Class II | Z-1651-2018 | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. |
| Nov 10, 2015 | Class II | Z-0460-2016 | Nonconforming Material/Component | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste… |
| Nov 10, 2015 | Class II | Z-0461-2016 | Nonconforming Material/Component | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste… |
| Apr 2, 2015 | Class II | Z-1615-2015 | Under Investigation by firm | Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical… |
| May 27, 2014 | Class III | Z-2133-2014 | Employee error | There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension… |
| Jul 17, 2012 | Class II | Z-2182-2012 | Device Design | Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K963498.
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. 2011, this device’s year, is highlighted.
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?
Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used for diagnosis in diseases with high and low Potassium levels. Chloride measurements are primarily use to detect and treatment of metabolic disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell…
Read the full statement (153 words)
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used for diagnosis in diseases with high and low Potassium levels.
Chloride measurements are primarily use to detect and treatment of metabolic disorders.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders.
Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112999 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112999: Dimension 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/K112999
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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