PMA · Approved
ApprovedEmit 2000 Cyclosporine Specific Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MKW Cyclosporine
Approved on Oct 2, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 1,556-day review. 1 later device descends from it.
- Decided
- Oct 2, 1996
- Review
- 1,556 days
- Class
- Class II
- Product code
- MKW
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceP920031 Emit 2000 Cyclosporine Specific AssayDade Behring, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK023208 Cedia Cyclosporine Plus AssayMicrogenics Corp. · 2002
Most influential descendants
Showing 1 of 1 · See all- K023208Cedia Cyclosporine Plus AssayMicrogenics Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P920031 | Emit 2000 Cyclosporine Specific Assay | Dade Behring, Inc. | 1996 | — |
| +1 | K023208 | Cedia Cyclosporine Plus Assay | Microgenics Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKW? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023208 | Cedia Cyclosporine Plus Assay | 2002 | 0 |
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, K023208 (Microgenics Corp., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MKW devicesMKW Cyclosporine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKW
3in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MKW
177in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKW
8in 2025
MAUDE reports naming product code MKW, 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 | — | 0 | 0 |
| 2008 | 3 | 177 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 0 | — | 1 | 108 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 1 | 30 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P920031 · printed Nov 6, 2026
Cite this page
510(k) Report. “P920031: Emit 2000 Cyclosporine Specific Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P920031
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026