Daavlin Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Daavlin Co.” (first 1982, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 3 | 3 |
Plus 1 more product codes.
Review panels
Most recent Daavlin Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063621 | 3 SERIES PHOTOTHERAPY CABINET | FTC | 2007-01-17 | 43 |
| K930856 | PSORALITE | FTC | 1993-08-26 | 189 |
| K854498 | SPECTRA 724 | FTC | 1985-11-25 | 13 |
| K828654 | UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305 | — | 1983-01-03 | 48 |
| K827690 | SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE | — | 1982-10-05 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Daavlin Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Daavlin Distributing Co. (18 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Daavlin Co.?
FDA lists 5 510(k) clearances under the applicant name “Daavlin Co.” (first 1982, latest 2007), across 2 product codes 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 Daavlin Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Daavlin Co. is 43 days.
Which FDA product codes appear under Daavlin Co.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 3).
Next steps
- See all 5 Daavlin Co. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Daavlin Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.