Bionime Corporation: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Bionime Corporation” (first 2005, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 170 days. Since 2017 the median was 253 days, against 171 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 | 3 | 172 |
| 2013 | 2 | 74 |
| 2014 | 1 | 206 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 238 |
| 2018 | 2 | 264 |
| 2019 | 1 | 89 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 168 |
| 2023 | 0 | — |
| 2024 | 2 | 255 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bionime Corporation took a median 253 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 18 | 18 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 | 1 |
Review panels
Most recent Bionime Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | 2024-11-04 | 243 |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | 2024-01-19 | 267 |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | QRL | 2022-09-26 | 168 |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | NBW | 2019-06-02 | 89 |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | NBW | 2018-08-17 | 266 |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | NBW | 2018-06-19 | 263 |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | NBW | 2017-07-06 | 170 |
| K161790 | iGlucose Blood Glucose Monitoring System | NBW | 2017-05-02 | 307 |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | NBW | 2014-08-22 | 206 |
| K133003 | RIGHTEST CONTROL SOLUTION | JJX | 2013-10-24 | 29 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bionime Corporation.
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.
- Bionime Coporation (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bionime Corporation?
FDA lists 21 510(k) clearances under the applicant name “Bionime Corporation” (first 2005, latest 2024), across 4 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 Bionime Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bionime Corporation is 170 days. Since 2017: 253 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bionime Corporation?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 18); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1); JQP (Calculator/Data Processing Module, For Clinical Use, 1).
Next steps
- See all 21 Bionime Corporation clearances with predicates and recalls
- Run predicate analysis for product code NBW, Bionime Corporation'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.