510(k) · Cleared
ClearedIMMULITE/IMMULITE® 1000 Cortisol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Products, Ltd. · CGR Radioimmunoassay, Cortisol
Cleared on Jan 15, 2021 as substantially equivalent to K931409 (Diagnostic Products Corp., 1993) after a 71-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jan 15, 2021
- Review
- 71 days
- Class
- Class II
- Product code
- CGR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931409 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931409 Immulite CortisolDiagnostic Products Corp. · 1993 · Recalled
- This deviceK203270 IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931409 | Immulite Cortisol | Diagnostic Products Corp. | 1993 | 1 |
| 0 (this device) | K203270 | IMMULITE/IMMULITE® 1000 Cortisol | Siemens Healthcare Diagnostics Products, Ltd. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931409 | Immulite CortisolSummary page 4…CRG Regulation Number: 21 CFR 862.1205 G. Predicate Device: Device Name: IMMULITE/IMMULITE® 1000 Cortisol 510(k) Number: K931409 Siemens Healthcare Diagnostics Products Ltd., Llanberis UK Section 008; Page 1 of 7 Traditional 510(k): IMMULITE… | 1993 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K931409.
How does its category compare?
All CGR devicesCGR Radioimmunoassay, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 | — |
What is it indicated for?
For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers — for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203270: IMMULITE/IMMULITE® 1000 Cortisol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203270
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026