Sudormed, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sudormed, Inc.” (first 1990, latest 1996), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 707 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 5 | 5 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 1 | 1 |
Review panels
Most recent Sudormed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K936135 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION | LAT | 1996-06-10 | 895 |
| K936240 | SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) | JKA | 1996-03-19 | 810 |
| K935588 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION | JKA | 1995-07-14 | 604 |
| K935564 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION | JKA | 1995-07-14 | 603 |
| K926253 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE | JKA | 1995-07-14 | 942 |
| K902442 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER | JKA | 1990-10-04 | 125 |
Recalls
openFDA lists no recalls under a recalling firm named Sudormed, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sudormed, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sudormed, Inc.” (first 1990, latest 1996), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sudormed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sudormed, Inc. is 707 days.
Which FDA product codes appear under Sudormed, Inc.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 5); LAT (Radioimmunoassay, Cannabinoid(S), 1).
Next steps
- See all 6 Sudormed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Sudormed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.