Localmed, Inc.: FDA clearances and approvals
Localmed, Inc. has 5 FDA 510(k) clearances (first 1994, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time: 80 days.
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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 4 | 4 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Localmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980957 | KAPLAN-SIMPSON INFUSASLEEVE II | QEY | 1998-06-10 | 86 |
| K972175 | INFUSASLEEVE IIA (IS-2A) | QEY | 1997-08-28 | 80 |
| K952317 | Kaplan-Simpson InfusaSleeve II Catheter | QEY | 1995-06-28 | 42 |
| K950615 | KAPLAN-SIMPSON INFUSASLEEVE CATHETER | QEY | 1995-04-19 | 68 |
| K935349 | LOCALMED INFUSION CATHETER | KRA | 1994-10-18 | 347 |
Recalls
openFDA lists no recalls under a recalling firm named Localmed, Inc..
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 Localmed, Inc. have?
Localmed, Inc. has 5 FDA 510(k) clearances (first 1994, latest 1998), across 2 product codes in 1 review panel.
How long does FDA take to clear Localmed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Localmed, Inc.'s cleared 510(k)s is 80 days.
What devices does Localmed, Inc. make?
Its most frequent FDA product codes are QEY (Mechanical Thrombolysis Catheter, 4); KRA (Catheter, Continuous Flush, 1).
Has Localmed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Localmed, Inc. Related entities may recall under other names.
Next steps
- See all 5 Localmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEY, Localmed, 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.