510(k) · Cleared
Recalled · 2010Access Cortisol Assay (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · CGR Radioimmunoassay, Cortisol
Cleared on Dec 5, 1995 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 1995
- Review
- 64 days
- Class
- Class II
- Product code
- CGR
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK954733 Access Cortisol Assay (Modification)Bio-Rad Laboratories, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK050202 Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK242190 Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK223038 Access CortisolBeckman Coulter, Inc. · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K050202Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2005 · cites it directly2descendants
- K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. · 2025 · 2 generations on0descendants
- K223038Access CortisolBeckman Coulter, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954733 | Access Cortisol Assay (Modification) | Bio-Rad Laboratories, Inc. | 1995 | — |
| +1 | K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2005 | 1 |
| +2 | K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025 | 4 |
| +2 | K223038 | Access Cortisol | Beckman Coulter, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 CGR? 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 CGR device
- #1 K242190 Access Cortisol; DxC 500i Clinical Analyzerscore 7.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay Systems | 2005 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2010 | Not classified | Z-2621-2010 | Other | The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050202 (Beckman Coulter, Inc., 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGR devicesCGR Radioimmunoassay, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGR
113in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGR
1in 2018
MAUDE reports naming product code CGR, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 3 | 113 | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954733 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954733: Access Cortisol Assay (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954733
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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