510(k) · Cleared
Recalled · Class II · 2018Lipase Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dupont Medical Products · CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Cleared on Jul 20, 1995 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Jul 20, 1995
- Review
- 30 days
- Class
- Class I
- Product code
- CHI
- Recalls
- 3
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 CHI? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Sep 7, 2018 | Class II | Z-0466-2019 | Under Investigation by firm | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. |
| Sep 7, 2018 | Class II | Z-0465-2019 | Under Investigation by firm | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. |
| Mar 10, 2010 | Not classified | Z-0588-2011 | Other | Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CHI devicesCHI Lipase-Esterase, Enzymatic, Photometric, Lipase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHI
FDA has decided no CHI device since 2007.
Median 510(k) review, days · CHI
Too few CHI 510(k)s in any year since 2007 to give a median.
Recalls per year · CHI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHI
11in 2025
MAUDE reports naming product code CHI, 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 | — | 1 | 0 |
| 2008 | 0 | — | 4 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 3 | 6 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 4 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952816: Lipase Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952816
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026