510(k) · Cleared
Recalled · Class II · 2023Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Jan 18, 2005 after a 26-day review. The FDA summary names its predicate without a number. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 18, 2005
- Review
- 26 days
- Class
- Class I
- Product code
- CDT
- Recalls
- 3
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK043546 Dimension RXL Max with Streamlab Analytical Workcell and Sample…Dade Behring, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 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
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · cites it directly4descendants
- K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · cites it directly4descendants
- K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 2 generations on3descendants
- K093318Accelerator ApsAbbott Laboratories · 2010 · 2 generations on3descendants
- K213486GLP systems TrackAbbott Laboratories · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module | Dade Behring, Inc. | 2005 | — |
| +1 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| +1 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| +2 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
| +2 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| +3 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 CDT? 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 |
|---|---|---|---|
| * | — | Dimension RxL Max Named without a submission number |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090588 | Power Processor Sample Processing System with Generic Connection Module, Model: 4210 | 2009 | 4 |
| K082638 | Advia Centaur System with Streamlab Analytical Workcell | 2009 | 4 |
| K160990 | Nova Max Uric Acid Monitoring System | 2017 | 1 |
| K083339 | Dimension RXL Max with Advia Modular Automation System (Amas) | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2023 | Class II | Z-2091-2023 | Under Investigation by firm | A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed… |
| Oct 6, 2021 | Class II | Z-0193-2022 | Software design | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and… |
| Sep 1, 2009 | Not classified | Z-1205-2010 | Software design | Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090588 (Beckman Coulter, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CDT devicesCDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · CDT
Too few CDT 510(k)s in any year since 2007 to give a median.
Recalls per year · CDT
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDT
12in 2025
MAUDE reports naming product code CDT, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 0 | — | 3 | 12 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension®'9 RxIL Max TM with StrCamLAl3B Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various sleps such as pipetting, preparing filtrates, heating, and measuring color inictnsitv. This device is intended for usc in conjunction with certain materials to micasure a variety of analyles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043546
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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