Daun International, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Daun International, Inc.” (first 1985, latest 1985), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| INM | Chair, With Casters | 2 | 2 |
| FMS | Bed, Pediatric Open Hospital | 1 | 1 |
| FNJ | Bed, Manual | 1 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 | 1 |
Review panels
Most recent Daun International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852174 | MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 | KNC | 1985-09-06 | 109 |
| K851553 | MERIUAARA & ERACARE WHEELCHAIRS | IOR | 1985-07-09 | 84 |
| K851550 | MERIVAARA GERIATRIC CHAIR | INM | 1985-07-09 | 84 |
| K851548 | AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS | INM | 1985-07-09 | 84 |
| K852173 | MERIVAARA CRIB TROLLEY-MODEL 381 | FMS | 1985-06-17 | 28 |
| K851552 | MERIVAARA HOSPITAL BED | FNJ | 1985-05-08 | 22 |
| K851551 | MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES | FNL | 1985-05-08 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Daun International, 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 Daun International, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Daun International, Inc.” (first 1985, latest 1985), across 6 product codes in 3 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 Daun International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Daun International, Inc. is 84 days.
Which FDA product codes appear under Daun International, Inc.?
The most frequent FDA product codes under this applicant name are INM (Chair, With Casters, 2); FMS (Bed, Pediatric Open Hospital, 1); FNJ (Bed, Manual, 1).
Next steps
- See all 7 Daun International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INM, Daun International, 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.