Crown Delta Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Crown Delta Corp.” (first 1976, latest 2013), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 66 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 | 1 | 233 |
| 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 |
|---|---|---|---|
| ELW | Material, Impression | 10 | 10 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 2 | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
| EWD | Protector, Hearing (Insert) | 1 | 1 |
Review panels
Most recent Crown Delta Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122974 | TRYOUT-VPS HOLDING PASTE | EMA | 2013-05-17 | 233 |
| K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | 2004-05-14 | 23 |
| K955288 | HEARING AID IMPRESSION MATERIAL | ESD | 1996-02-02 | 78 |
| K940132 | PODIATRIC MATERIAL | MNE | 1994-09-29 | 269 |
| K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW | 1994-01-07 | 353 |
| K926150 | VINYL ADDITION SILICONE SYSTEM | ESD | 1993-07-14 | 219 |
| K901991 | SILICONE ELASTOMER PUTTY | MDA | 1990-09-14 | 135 |
| K901990 | VINYL SILICONE ELASTOMER MATERIAL | MDA | 1990-09-14 | 135 |
| K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM | ELW | 1987-07-21 | 8 |
| K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM | ELW | 1987-06-11 | 64 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Crown Delta 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.
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.
- Crown Aesthetics (3 510(k)s)
- Crown Name Disposable Hygiene Products Fty., Ltd. (2 510(k)s)
- Crown Porcelain Dental Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Crown Delta Corp.?
FDA lists 18 510(k) clearances under the applicant name “Crown Delta Corp.” (first 1976, latest 2013), across 6 product codes in 4 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 Crown Delta Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Crown Delta Corp. is 66 days.
Which FDA product codes appear under Crown Delta Corp.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 10); ESD (Hearing Aid, Air-Conduction, Prescription, 2); MDA (Elastomer, Silicone, For Scar Management, 2).
Next steps
- See all 18 Crown Delta Corp. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Crown Delta 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.