George King Bio-Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “George King Bio-Medical, Inc.” (first 1995, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 340 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 | 1 | 288 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name George King Bio-Medical, Inc. took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | 3 | 3 |
| GGC | Control, Plasma, Abnormal | 1 | 1 |
| GJT | Plasma, Coagulation Factor Deficient | 1 | 1 |
Review panels
- Hematology (5)
Most recent George King Bio-Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161316 | George King Coumadin Plasma | GGN | 2017-02-23 | 288 |
| K945855 | A-FACT, ABNORMAL FACTOR ASSAY CONTROL | GGN | 1995-10-24 | 344 |
| K945854 | B-FACT, BORDERLINE FACTOR ASSAY CONTROL | GGN | 1995-10-24 | 344 |
| K945857 | PROTEIN C DEFICIENT PLASMA | GJT | 1995-10-20 | 340 |
| K945856 | POSITIVE LUPUS ANTICOAGULANT PLASMA | GGC | 1995-10-05 | 325 |
Recalls
openFDA lists no recalls under a recalling firm named George King Bio-Medical, Inc..
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 George King Bio-Medical, Inc. (a text match, not an official crosswalk):
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.
- George M. Wilson, Dds (3 510(k)s)
- George Courey, Inc. (2 510(k)s)
- George H. Frisch (2 510(k)s)
- George Taub Products & Fusion Co., Inc. (2 510(k)s)
- George C. Kuhn (1 510(k)s)
- George Glove Company, Inc. (1 510(k)s)
- George J. Kamilar (1 510(k)s)
- George Loo, MD (1 510(k)s)
- George Percy Mcgown (1 510(k)s)
- George Tiemann & Co. (1 510(k)s)
- George W. Cottrell (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under George King Bio-Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “George King Bio-Medical, Inc.” (first 1995, latest 2017), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by George King Bio-Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name George King Bio-Medical, Inc. is 340 days.
Which FDA product codes appear under George King Bio-Medical, Inc.?
The most frequent FDA product codes under this applicant name are GGN (Plasma, Coagulation Control, 3); GGC (Control, Plasma, Abnormal, 1); GJT (Plasma, Coagulation Factor Deficient, 1).
Next steps
- See all 5 George King Bio-Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGN, George King Bio-Medical, Inc.'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.