510(k) · Cleared
ClearedPhenobarbital Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dupont Medical Products · DLZ Enzyme Immunoassay, Phenobarbital
Cleared on Dec 28, 1994 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 28, 1994
- Review
- 83 days
- Class
- Class II
- Product code
- DLZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK944932 Phenobarbital Flex Reagent CartridgeDupont Medical Products · 1994
- Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
- K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 2 generations on1descendant
- K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · 2 generations on1descendant
- K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
- K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944932 | Phenobarbital Flex Reagent Cartridge | Dupont Medical Products | 1994 | — |
| +1 | K051087 | Dimension Vista Integrated System | Dade Behring, Inc. | 2005 | 32 |
| +2 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| +2 | K061838 | Dimension Vista Chemistry 1 Calibrator, Model KC110 | Dade Behring, Inc. | 2006 | 3 |
| +2 | K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | 2015 | 5 |
| +3 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium… | Siemens Healthcare Diagnostics | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2015 | 2 | 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 DLZ? 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 DLZ device
- #1 K210858 VITROS Chemistry Products PHBR Slidesscore 2.1 · 2 generations · no Class I recall
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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051087 | Dimension Vista Integrated System | 2005 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DLZ devicesDLZ Enzyme Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLZ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DLZ
Too few DLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLZ
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLZ
1in 2024
MAUDE reports naming product code DLZ, 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 | 3 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 58 |
| 2012 | 0 | — | 2 | 222 |
| 2013 | 1 | — | 2 | 101 |
| 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944932: Phenobarbital 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/K944932
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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