Apex BioTechnology Corp.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Apex BioTechnology Corp.” (first 2001, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 146 days. Since 2017 the median was 249 days, against 223 days for all cleared 510(k)s in the same product codes. 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 | 5 | 90 |
| 2013 | 0 | — |
| 2014 | 1 | 265 |
| 2015 | 4 | 278 |
| 2016 | 1 | 228 |
| 2017 | 1 | 41 |
| 2018 | 2 | 60 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 408 |
| 2022 | 5 | 263 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 249 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Apex BioTechnology Corp. took a median 249 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 18 | 18 |
| CGA | Glucose Oxidase, Glucose | 14 | 14 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| PTC | Uric Acid Test System For At Home Prescription Use | 1 | 1 |
Review panels
- Clinical Chemistry (35)
Most recent Apex BioTechnology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring System | PTC | 2025-04-04 | 249 |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | NBW | 2022-12-21 | 148 |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | NBW | 2022-11-04 | 263 |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | NBW | 2022-08-25 | 413 |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | NBW | 2022-04-06 | 582 |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | NBW | 2022-03-29 | 106 |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | NBW | 2021-10-15 | 465 |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | NBW | 2021-09-15 | 352 |
| K182593 | KET-1 Blood Ketone Monitoring System | JIN | 2018-12-18 | 89 |
| K182992 | BGM014 Blood Glucose Monitoring System | NBW | 2018-11-28 | 30 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Apex BioTechnology 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.
- Apex Medical Corp. (36 510(k)s)
- Apex Dental Materials, Inc. (15 510(k)s)
- Apex Medical Technologies, Inc. (8 510(k)s)
- Apex Surgical, LLC (6 510(k)s)
- Apex Metal, Inc. (3 510(k)s)
- Apex Tools & Orthopedics Co. (2 510(k)s)
- Apex Ent., Inc. (1 510(k)s)
- Apex Imaging Corp. (1 510(k)s)
- Apex Medical Products, LLC (1 510(k)s)
- Apex Optical Ind. Co. (1 510(k)s)
- Apex Orthodontics, Inc. (1 510(k)s)
- Apex Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apex BioTechnology Corp.?
FDA lists 35 510(k) clearances under the applicant name “Apex BioTechnology Corp.” (first 2001, latest 2025), across 5 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 Apex BioTechnology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apex BioTechnology Corp. is 146 days. Since 2017: 249 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Apex BioTechnology Corp.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 18); CGA (Glucose Oxidase, Glucose, 14); JIN (Nitroprusside, Ketones (Urinary, Non-Quant.), 1).
Next steps
- See all 35 Apex BioTechnology Corp. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Apex BioTechnology 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.