510(k) · Cleared
ClearedNichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample Diluent)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · CIB Radioimmunoassay, Angiotensin I And Renin
Cleared on Sep 6, 2001 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Sep 6, 2001
- Review
- 146 days
- Class
- Class II
- Product code
- CIB
- Recalls
- None
- 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 CIB? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CIB devicesCIB Radioimmunoassay, Angiotensin I And Renin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIB
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CIB
Too few CIB 510(k)s in any year since 2007 to give a median.
Recalls per year · CIB
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIB
No MAUDE report names CIB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011128: Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample Diluent).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011128
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026