Dna Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dna Medical, Inc.” (first 1982, latest 1983), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (3)
- Anesthesiology (1)
Most recent Dna Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833659 | IV EXTENSION SET | FPK | 1983-11-29 | 42 |
| K832878 | GOAL TENDER | BWF | 1983-10-14 | 49 |
| K822891 | FLO CONTROL | LDR | 1982-11-24 | 57 |
| K821929 | SUBCLAVIAN | FOZ | 1982-07-08 | 9 |
| K820628 | J-CATHETER | — | 1982-04-06 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Dna Medical, 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 Dna Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Dna Medical, Inc.” (first 1982, latest 1983), across 5 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 Dna Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dna Medical, Inc. is 42 days.
Which FDA product codes appear under Dna Medical, Inc.?
The most frequent FDA product codes under this applicant name are BWF (Spirometer, Therapeutic (Incentive), 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); FPK (Tubing, Fluid Delivery, 1).
Next steps
- See all 5 Dna Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BWF, Dna Medical, 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.