Daavlin Distributing Co.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Daavlin Distributing Co.” (first 2002, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 71 days. Since 2017 the median was 39 days, against 90 days for all cleared 510(k)s in the same product codes. 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 | 1 | 70 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 88 |
| 2022 | 1 | 30 |
| 2023 | 2 | 26 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Daavlin Distributing Co. took a median 39 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 14 | 14 |
| ONE | Powered Light Based Non-Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Daavlin Distributing Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233811 | DT Controlled Phototherapy Equipment | FTC | 2023-12-13 | 14 |
| K230382 | 3 Series NeoLux | FTC | 2023-03-24 | 39 |
| K220840 | 1 Series Phototherapy Equipment | FTC | 2022-04-22 | 30 |
| K212510 | 7 Series Phototherapy Device | FTC | 2021-11-04 | 86 |
| K210881 | M Series Phototherapy Equipment | FTC | 2021-06-22 | 89 |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | FTC | 2015-09-10 | 70 |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | FTC | 2011-10-20 | 202 |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | FTC | 2011-08-29 | 125 |
| K100628 | PLASMALUXLS | ONE | 2010-11-24 | 264 |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | FTC | 2010-04-28 | 71 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Daavlin Distributing 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 Co. (5 510(k)s)
- Daavlin Distributing Company (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Daavlin Distributing Co.?
FDA lists 15 510(k) clearances under the applicant name “Daavlin Distributing Co.” (first 2002, latest 2023), 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 Distributing Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Daavlin Distributing Co. is 71 days. Since 2017: 39 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Daavlin Distributing Co.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 14); ONE (Powered Light Based Non-Laser Surgical Instrument, 1).
Next steps
- See all 15 Daavlin Distributing Co. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Daavlin Distributing 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, 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.