Williams Medical Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Williams Medical Co.” (first 1985, latest 1989), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| KPE | Container, I.V. | 4 | 4 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Review panels
Most recent Williams Medical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891159 | SODIUM BICARBONATE, U.S.P. | KPO | 1989-04-07 | 32 |
| K854034 | SNAP-LOCK ADDITIVE CAP #SL 300 | KPE | 1985-11-06 | 36 |
| K854033 | SNAP-LOCK ADDITIVE CAP #SL400 | KPE | 1985-11-06 | 36 |
| K854031 | SNAP-LOCK ADDITIVE CAP #SL100 | KPE | 1985-11-06 | 36 |
| K854032 | SNAP-LOCK ADDITIVE CAP #SL 200 | KPE | 1985-11-01 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Williams Medical 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.
- Williams Gold Refining Co., Inc. (26 510(k)s)
- Williams Manufacturing Co. (4 510(k)s)
- Williams Sound, LLC (4 510(k)s)
- Williams Dental Co., Inc. (2 510(k)s)
- Williams Healthcare Systems, LLC (2 510(k)s)
- Williams Specialty Products, Inc. (2 510(k)s)
- Williams Airway Intubator (1 510(k)s)
- Williams & Connolly (1 510(k)s)
- Williams Importing Company, Inc. (1 510(k)s)
- Williams, the J.B. Co., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Williams Medical Co.?
FDA lists 5 510(k) clearances under the applicant name “Williams Medical Co.” (first 1985, latest 1989), 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 Williams Medical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Williams Medical Co. is 36 days.
Which FDA product codes appear under Williams Medical Co.?
The most frequent FDA product codes under this applicant name are KPE (Container, I.V., 4); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 1).
Next steps
- See all 5 Williams Medical Co. clearances with predicates and recalls
- Run predicate analysis for product code KPE, Williams Medical 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, 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.