510(k) · Cleared
ClearedEnzyme Immunoassay for the Detection of Salivary Cortisol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drg Intl., Inc. · NHG Enzyme Immunoassay, Cortisol, Salivary
Cleared on Dec 7, 2005 after a 162-day review. The FDA summary names no predicate by number.
- Decided
- Dec 7, 2005
- Review
- 162 days
- Class
- Class II
- Product code
- NHG
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 NHG? 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?
The FDA summary names no predicate by number.
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 NHG devicesNHG Enzyme Immunoassay, Cortisol, Salivary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHG
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NHG
Too few NHG 510(k)s in any year since 2007 to give a median.
Recalls per year · NHG
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHG
1in 2024
MAUDE reports naming product code NHG, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051733: Enzyme Immunoassay for the Detection of Salivary Cortisol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051733
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026