Biolinq Incorporated: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Biolinq Incorporated” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 53 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 |
|---|---|---|
| 2026 | 1 | 53 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biolinq Incorporated took a median 53 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 53 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SFU | Glucose Range Monitoring System | 2 | 1 |
Review panels
Most recent Biolinq Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | SFU | 2026-09-18 | 53 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240080 | De Novo | Glucose Range Monitoring System | 2025-09-23 |
Recalls
openFDA lists no recalls under a recalling firm named Biolinq Incorporated.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biolinq Incorporated?
FDA lists 1 510(k) clearance under the applicant name “Biolinq Incorporated” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code 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 Biolinq Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biolinq Incorporated is 53 days.
Which FDA product codes appear under Biolinq Incorporated?
The most frequent FDA product codes under this applicant name are SFU (Glucose Range Monitoring System, 2).
Next steps
- See all 1 Biolinq Incorporated clearances with predicates and recalls
- Run predicate analysis for product code SFU, Biolinq Incorporated'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.