Lone Star Medical Products, Inc.: FDA clearances and approvals
Lone Star Medical Products, Inc. has 6 FDA 510(k) clearances (first 1979, latest 1985), across 3 product codes in 2 review panels. Median 510(k) review time: 42 days. openFDA lists 3 product recalls by a recalling firm named Lone Star Medical Products, Inc.
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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 3 | 3 |
| GAD | Retractor | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Lone Star Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850041 | P-3 CLOSING INSTRUMENT | — | 1985-02-21 | 45 |
| K831531 | SURGICAL ISOLATION BARRIER SYSTEM | — | 1984-06-05 | 391 |
| K820015 | URETHAL CUTTER CLAMP | KOA | 1982-02-22 | 48 |
| K810915 | THE SCOTT DIALMENZENSERT | KOA | 1981-05-08 | 32 |
| K802983 | THE INQUINAL RESORVOIR INSERTER | KOA | 1980-12-30 | 39 |
| K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC | GAD | 1979-09-19 | 29 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-10-06.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Lone Star Medical Products, Inc. have?
Lone Star Medical Products, Inc. has 6 FDA 510(k) clearances (first 1979, latest 1985), across 3 product codes in 2 review panels.
How long does FDA take to clear Lone Star Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lone Star Medical Products, Inc.'s cleared 510(k)s is 42 days.
What devices does Lone Star Medical Products, Inc. make?
Its most frequent FDA product codes are KOA (Surgical Instruments, G-U, Manual (And Accessories), 3); GAD (Retractor, 1).
Has Lone Star Medical Products, Inc. had device recalls?
openFDA lists 3 product recalls in 1 recall event by a recalling firm whose name matches Lone Star Medical Products, Inc; the most recent began 2004-10-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Lone Star Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOA, Lone Star Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.