510(k) · Cleared
Recalled · Class II · 2022Dimension (TM) 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. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Jun 11, 1986 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 11, 1986
- Review
- 37 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 6 citing it directly.
- This deviceK861700 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986
- Descendant · cites it directly · 1 of its ownK061719 Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista…Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK060628 Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi…Dade Behring, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK222104 Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK162399 Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K061719Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator…Dade Behring, Inc. · 2006 · cites it directly1descendant
- K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · cites it directly1descendant
- K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc. · 2006 · cites it directly1descendant
- K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861700 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | — |
| +1 | K061719 | Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil… | Dade Behring, Inc. | 2006 | 2 |
| +1 | K061655 | Dimension Vista Flex Reagent Cartridges | Dade Behring, Inc. | 2006 | 7 |
| +1 | K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator | Dade Behring, Inc. | 2006 | 1 |
| +2 | K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +1 | K162399 | Atellica CH Magnesium (Mg) | Siemens Healthcare Diagnostics, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061719 | Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator… | 2006 | 1 |
| K061655 | Dimension Vista Flex Reagent Cartridges | 2006 | 1 |
| K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator | 2006 | 1 |
| K162399 | Atellica CH Magnesium (Mg) | 2017 | 0 |
| K061702 | Dimension Vista System Creatine Kinase Calibrator (CK Cal - KC340) | 2006 | 0 |
| K061020 | Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase… | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2022 | Class II | Z-1816-2022 | Under Investigation by firm | Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an… |
| Feb 22, 2013 | Class II | Z-1049-2013 | Device Design | Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061719 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K861700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861700: Dimension (TM) Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861700
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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