510(k) · Cleared
Recalled · Class II · 2022Dimension Vista HDLC Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JHM Colorimetric Method, Lipoproteins
Cleared on Jul 2, 2008 as substantially equivalent to K073072 (Dade Behring, Inc., 2008) after a 55-day review. Its family tree reaches back 3 generations to 1999. It has been recalled 2 times.
- Decided
- Jul 2, 2008
- Review
- 55 days
- Class
- Class I
- Product code
- JHM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983849 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
- 2 generations backK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
- 1 generation backK073072 Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 2008 · Recalled
- This deviceK081300 Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… | Dade Behring, Inc. | 1999 | — |
| −2 | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)… | Dade Behring, Inc. | 2003 | — |
| −1 | K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48B | Dade Behring, Inc. | 2008 | 2 |
| 0 (this device) | K081300 | Dimension Vista HDLC Flex Reagent Cartridge | Siemens Healthcare Diagnostics | 2008 | — |
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 JHM? 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 |
|---|---|---|---|
| * | K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BSummary page 1…Vista® HDLC Flex® reagent cartridge (K3408A) / Class I 3. Identification of the Predicate Device * Dimension® AHDL Flex® reagent cartridge (K073072) FDA Guidance Document(s): * "Replacement Reagent and Instrument Family Policy" - 12/11/2003… | 2008 |
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 |
|---|---|---|---|---|
| Aug 24, 2022 | Class II | Z-0089-2023 | Under Investigation by firm | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to… |
| Feb 3, 2021 | Class II | Z-1188-2021 | Under Investigation by firm | Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All JHM devicesJHM Colorimetric Method, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JHM
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JHM
Too few JHM 510(k)s in any year since 2007 to give a median.
Recalls per year · JHM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHM
No MAUDE report names JHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081300: Dimension Vista HDLC Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081300
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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