Deroyal: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Deroyal” (first 2002, latest 2004), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| FYA | Gown, Surgical | 2 | 2 |
| EYC | Catheter, Upper Urinary Tract | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 1 | 1 |
Review panels
Most recent Deroyal 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | EYC | 2004-07-02 | 36 |
| K033057 | DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE | FYA | 2003-11-20 | 52 |
| K031408 | DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) | FYA | 2003-10-15 | 163 |
| K030908 | DEROYAL SURGICAL DRAPES BACKTABLE COVER | KKX | 2003-08-11 | 140 |
| K020753 | DEROYAL SURGICAL, UMBILICUP | KSR | 2002-06-13 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Deroyal.
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.
- Deroyal Industries, Inc. (92 510(k)s)
- Deroyal Cardiovascular, Inc. (1 510(k)s)
- Deroyal Critical Care, Div. Deroyal Technologies (1 510(k)s)
- Deroyal Surgical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Deroyal?
FDA lists 5 510(k) clearances under the applicant name “Deroyal” (first 2002, latest 2004), across 4 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 Deroyal?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deroyal is 98 days.
Which FDA product codes appear under Deroyal?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 2); EYC (Catheter, Upper Urinary Tract, 1); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 5 Deroyal clearances with predicates and recalls
- Run predicate analysis for product code FYA, Deroyal'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.