InBios International, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “InBios International, Inc.” (first 2014, latest 2025), plus 2 De Novo decisions, across 7 product codes in 1 review panel. Median 510(k) review time under this name: 155 days. Since 2017 the median was 138 days, against 180 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 |
|---|---|---|
| 2014 | 1 | 177 |
| 2015 | 0 | — |
| 2016 | 1 | 155 |
| 2017 | 0 | — |
| 2018 | 1 | 84 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 329 |
| 2025 | 1 | 138 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name InBios International, Inc. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | 1 | 1 |
| PIT | Leishmania Spp. Antigen Detection Assay | 1 | 1 |
| QCU | Dengue Virus Antigen Assay | 1 | 1 |
| QFO | Zika Virus Serological Reagents | 1 | 0 |
| QUU | Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples | 1 | 0 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 | 1 |
Review panels
- Microbiology (7)
Most recent InBios International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251595 | COVID-19 Detect Rapid Self -Test | QYT | 2025-10-12 | 138 |
| K233358 | SCoV-2 Ag Detect Rapid Test | QVF | 2024-08-23 | 329 |
| K181473 | DENV Detect NS1 ELISA | QCU | 2018-08-27 | 84 |
| K161947 | Chagas Detect Plus Rapid Test | MIU | 2016-12-16 | 155 |
| K141341 | CL DETECT RAPID TEST | PIT | 2014-11-14 | 177 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220044 | De Novo | Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples | 2023-02-03 |
| DEN180069 | De Novo | Zika Virus Serological Reagents | 2019-05-23 |
Recalls
openFDA lists no recalls under a recalling firm named InBios International, 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.
Device clinical trials
An industry sponsor named InBios International, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03776903: Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA (Completed, started 2018-04-01)
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.
- Inbios Intl., Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under InBios International, Inc.?
FDA lists 5 510(k) clearances under the applicant name “InBios International, Inc.” (first 2014, latest 2025), plus 2 De Novo decisions, across 7 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 InBios International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name InBios International, Inc. is 155 days. Since 2017: 138 days, versus 180 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under InBios International, Inc.?
The most frequent FDA product codes under this applicant name are MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi, 1); PIT (Leishmania Spp. Antigen Detection Assay, 1); QCU (Dengue Virus Antigen Assay, 1).
Next steps
- See all 5 InBios International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MIU, InBios International, 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 (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.