510(k) · Cleared
Recalled · Class II · 2018Dimension Exl with LM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Mar 22, 2013 as substantially equivalent to K073604 (Dade Behring, Inc., 2008) after a 45-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Mar 22, 2013
- Review
- 45 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970389 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK970389 Thyroid CalibratorDade Chemistry Systems, Inc. · 1997
- 2 generations backK053531 Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1…Dade Behring, Inc. · 2006
- 1 generation backK073604 Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex…Dade Behring, Inc. · 2008 · Recalled
- This deviceK130276 Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140842 Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970389 | Thyroid Calibrator | Dade Chemistry Systems, Inc. | 1997 | — |
| −2 | K053531 | Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator | Dade Behring, Inc. | 2006 | — |
| −1 | K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent… | Dade Behring, Inc. | 2008 | 7 |
| 0 (this device) | K130276 | Dimension Exl with LM System | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +1 | K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci… | Siemens Healthcare Diagnostics, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…Summary page 2…o demonstrate substantial equivalence to the Dimension® EXLTM with LM system with the new photomultiplier tube (PMT) is the Dimension® EXLTM with LM system cleared under k073604 including the FT4L assay. The predicate device used to demonstrate substantial equivalence to the Dimension® FT4L Flex® reagent c… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid… | 2014 | 0 |
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 |
| Nov 10, 2015 | Class II | Z-0458-2016 | 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-0459-2016 | 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… |
| Jul 16, 2014 | Class II | Z-2553-2014 | Device Design | The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator. |
| 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… |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140842 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K073604.
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. 2013, 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?
The Dimension® EXLTM with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective muitisensor technology for chemical and immunochemnical applications for clinical use.
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130276: Dimension Exl with LM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130276
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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