Infusaid Corp.: FDA clearances and approvals
Infusaid Corp. has 8 FDA 510(k) clearances (first 1983, latest 1991), across 2 product codes in 2 review panels. Median 510(k) review time: 63 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 6 | 6 |
| DYB | Introducer, Catheter | 2 | 2 |
Review panels
- General Hospital (6)
- Cardiovascular (2)
Most recent Infusaid Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910448 | SNAP-LOCK MICRO PORT, MODIFICATION | LJT | 1991-11-21 | 303 |
| K901419 | DUAL PORT | LJT | 1990-09-05 | 163 |
| K902251 | SUBCLAVIAN INTRODUCER SET | DYB | 1990-07-31 | 76 |
| K860898 | SUBCLAVIAN INTRODUCER SET | DYB | 1986-04-29 | 50 |
| K840481 | INFUSE-A-PORT HEPARIN LOCK MAINT KIT | LJT | 1984-09-18 | 225 |
| K842355 | INFUSAID INFUSE-A-PORT | LJT | 1984-08-06 | 46 |
| K832788 | INFUSE-A-PORT | LJT | 1983-09-15 | 27 |
| K823838 | INFUSE-A-PORT | LJT | 1983-01-12 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Infusaid Corp..
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 Infusaid Corp. have?
Infusaid Corp. has 8 FDA 510(k) clearances (first 1983, latest 1991), across 2 product codes in 2 review panels.
How long does FDA take to clear Infusaid Corp.'s 510(k)s?
The median time from FDA receipt to decision across Infusaid Corp.'s cleared 510(k)s is 63 days.
What devices does Infusaid Corp. make?
Its most frequent FDA product codes are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 6); DYB (Introducer, Catheter, 2).
Has Infusaid Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Infusaid Corp. Related entities may recall under other names.
Next steps
- See all 8 Infusaid Corp. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Infusaid Corp.'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.