510(k) · Cleared
ClearedSudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sudormed, Inc. · LAT Radioimmunoassay, Cannabinoid (S)
Cleared on Jun 10, 1996 after an 895-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Jun 10, 1996
- Review
- 895 days
- Class
- Class II
- Product code
- LAT
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, 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 LAT? 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 lists a 510(k) statement for it but has not posted the file, 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 LAT devicesLAT Radioimmunoassay, Cannabinoid (S): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAT
FDA has decided no LAT device since 2007.
Median 510(k) review, days · LAT
Too few LAT 510(k)s in any year since 2007 to give a median.
Recalls per year · LAT
No recall names LAT since 2007.
Adverse event reports per year · LAT
No MAUDE report names LAT since 2007.
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 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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/K936135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K936135: Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K936135
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026