510(k) · Cleared
ClearedEmit Vancomycin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · LEH Radioimmunoassay, Vancomycin
Cleared on Apr 19, 1988 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 19, 1988
- Review
- 39 days
- Class
- Class II
- Product code
- LEH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK881040 Emit Vancomycin AssaySyva Co. · 1988
- Descendant · cites it directly · 1 of its ownK020692 Emit 2000 Vancomycin AssayDade Behring, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK020845 Emit 2000 Vancomycin CalibratorsDade Behring, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK043386 Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K020692Emit 2000 Vancomycin AssayDade Behring, Inc. · 2002 · cites it directly1descendant
- K020845Emit 2000 Vancomycin CalibratorsDade Behring, Inc. · 2002 · cites it directly1descendant
- K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881040 | Emit Vancomycin Assay | Syva Co. | 1988 | — |
| +1 | K020692 | Emit 2000 Vancomycin Assay | Dade Behring, Inc. | 2002 | — |
| +1 | K020845 | Emit 2000 Vancomycin Calibrators | Dade Behring, Inc. | 2002 | — |
| +2 | K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 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 LEH? 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 LEH device
- #1 K222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH…score 7.0 · 5 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K020692 (Dade Behring, Inc., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LEH devicesLEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LEH
Too few LEH 510(k)s in any year since 2007 to give a median.
Recalls per year · LEH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEH
14in 2025
MAUDE reports naming product code LEH, 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 | — | 2 | 4 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 0 | 55 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 40 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 2 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 2 | 13 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K881040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881040: Emit Vancomycin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881040
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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