Castle Co.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Castle Co.” (first 1976, latest 1987), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | 5 | 5 |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | 3 | 3 |
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
| FSY | Light, Surgical, Ceiling Mounted | 3 | 3 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 3 | 3 |
| LDS | Device, Pasteurization, Hot Water | 2 | 2 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Castle Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870975 | MODIFIED CASTLE POWERCLAVE | FLE | 1987-04-17 | 38 |
| K860263 | CASTLE 7538 FLOOR LOADING WASHER | LDS | 1986-03-05 | 37 |
| K844089 | CASTLE 7515 UTENSIL/GLASSWARE WASHER | LDS | 1985-01-14 | 84 |
| K834048 | BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO | GEI | 1984-04-04 | 133 |
| K833074 | CASTLE TEC-TEST S.M.A.R.T. PACK | JOJ | 1983-11-07 | 59 |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | FLI | 1983-06-15 | 29 |
| K792660 | 1500 EO EXHAUST HOOD | FLF | 1980-01-29 | 33 |
| K792649 | UNISPORE-BIOLOGICAL INDICATORS | FRC | 1980-01-29 | 39 |
| K790677 | EO EVACUATING SYSTEM I | FLI | 1979-05-07 | 28 |
| K781887 | 9100 DAYSTAR AND 9110 ORBITER PACKAGE | FSY | 1978-12-12 | 35 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Castle Co..
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.
- Castle Laser Systems, Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Castle Co.?
FDA lists 21 510(k) clearances under the applicant name “Castle Co.” (first 1976, latest 1987), across 8 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 Castle Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Castle Co. is 39 days.
Which FDA product codes appear under Castle Co.?
The most frequent FDA product codes under this applicant name are FLE (Sterilizer, Steam, 5); FLI (Cabinet, Ethylene-Oxide Gas Aerator, 3); FRC (Indicator, Biological Sterilization Process, 3).
Next steps
- See all 21 Castle Co. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Castle Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.