Exciton Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Exciton Technologies, Inc.” (first 2009, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 158 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 | 1 | 104 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 158 |
| 2018 | 1 | 71 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Exciton Technologies, Inc. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 7 | 7 |
Review panels
Most recent Exciton Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182680 | KerraContact Ag Perf Advanced Perforated Silver Wound Dressing | FRO | 2018-12-06 | 71 |
| K162508 | KerraCel Ag Gelling Fiber Silver Dressing | FRO | 2017-02-13 | 158 |
| K133775 | EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING | FRO | 2014-03-26 | 104 |
| K113564 | EXSALT T7 WOUND DRESSING | FRO | 2011-12-15 | 13 |
| K103067 | EXSALT SD7 WOUND DRESSING | FRO | 2011-05-20 | 214 |
| K100580 | EXSALT WOUND DRESSING | FRO | 2010-10-12 | 224 |
| K083870 | EXSALT SD7 WOUND DRESSING | FRO | 2009-07-30 | 213 |
Recalls
openFDA lists no recalls under a recalling firm named Exciton Technologies, 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.
Device clinical trials
An industry sponsor named Exciton Technologies, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05243810: EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers (Completed, started 2022-11-28)
- NCT02662101: Impact of Oxidized Silver Wound Dressings on Wound Bacteria (Completed, started 2014-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Exciton Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Exciton Technologies, Inc.” (first 2009, latest 2018), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Exciton Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exciton Technologies, Inc. is 158 days.
Which FDA product codes appear under Exciton Technologies, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 7).
Next steps
- See all 7 Exciton Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Exciton Technologies, 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.