Linton Biomed Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Linton Biomed Corp.” (first 1982, latest 1984), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 17 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 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
Review panels
- Cardiovascular (3)
- General Hospital (2)
Most recent Linton Biomed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841772 | HEPARIN CAP, INJECTION CAP MALE LUER- | FPA | 1984-07-06 | 67 |
| K831348 | FLUID ADMIN. SET AFS-1C | DRS | 1983-05-27 | 32 |
| K820202 | CONTINUOUS FLUSH DEVICE/FDI | DRS | 1982-02-12 | 17 |
| K820201 | DISPOS. MONITORING SYS/LI ET AL | DRS | 1982-02-12 | 17 |
| K820203 | FLUID ADMINISTRATIVE SET, AFI | FPA | 1982-02-05 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Linton Biomed 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Linton Biomed Corp.?
FDA lists 5 510(k) clearances under the applicant name “Linton Biomed Corp.” (first 1982, latest 1984), across 2 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 Linton Biomed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Linton Biomed Corp. is 17 days.
Which FDA product codes appear under Linton Biomed Corp.?
The most frequent FDA product codes under this applicant name are DRS (Transducer, Blood-Pressure, Extravascular, 3); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 5 Linton Biomed Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRS, Linton Biomed 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 (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.