Daum Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Daum Corp.” (first 1997, latest 2001), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | 9 | 9 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
Most recent Daum Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010037 | DAUM DOUBLE-SHOOT BISOPSY GUN | KNW | 2001-03-22 | 77 |
| K991366 | DAUM MRI/CONVENTIONAL BIOPSY KIT | KNW | 1999-06-25 | 66 |
| K990782 | DAUM NEUROGATE TROCAR | KNW | 1999-04-28 | 50 |
| K990278 | DAUM NEUROCUT NEUROBIOPSYNEEDLE | KNW | 1999-03-30 | 61 |
| K981320 | DAUM BONE BIOPSY SET | KNW | 1998-06-29 | 80 |
| K974631 | DAUM NEUROBIOPSY NEEDLE | KNW | 1998-03-09 | 87 |
| K974576 | DAUM BIOPSYGUN | KNW | 1998-03-06 | 88 |
| K974575 | DAUM ASPIRATIONBIOPSY NEEDLE | KNW | 1998-03-06 | 88 |
| K974574 | DAUM NEUROPUNCTURE NEEDLE | KNW | 1998-03-06 | 88 |
| K970037 | TARGOGRID | LNH | 1997-03-12 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Daum Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Daum Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Daum Corp.?
FDA lists 10 510(k) clearances under the applicant name “Daum Corp.” (first 1997, latest 2001), across 2 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 Daum Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Daum Corp. is 78 days.
Which FDA product codes appear under Daum Corp.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 9); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Next steps
- See all 10 Daum Corp. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Daum Corp.'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.