Strato/Infusaid, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Strato/Infusaid, Inc.” (first 1995, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 6 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 | 4 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (11)
Most recent Strato/Infusaid, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960391 | STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 | FPA | 1996-07-03 | 156 |
| K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM | LJT | 1996-01-26 | 183 |
| K954720 | STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS | LJS | 1996-01-04 | 83 |
| K953254 | STRATO/INFUSAID INFUSE-A-KIT | LJT | 1995-11-29 | 140 |
| K953436 | STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM | LJS | 1995-10-04 | 75 |
| K953256 | STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS | LJS | 1995-10-04 | 84 |
| K950987 | STRATO/INFUSAID TUNNELER | LJS | 1995-06-02 | 91 |
| K951875 | STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM | LJT | 1995-05-24 | 33 |
| K951874 | STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM | LJT | 1995-05-19 | 28 |
| K951873 | STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM | LJT | 1995-05-19 | 28 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Strato/Infusaid, Inc..
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 Strato/Infusaid, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Strato/Infusaid, Inc.” (first 1995, latest 1996), across 3 product codes 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 Strato/Infusaid, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Strato/Infusaid, Inc. is 83 days.
Which FDA product codes appear under Strato/Infusaid, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 6); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 4); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 11 Strato/Infusaid, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Strato/Infusaid, Inc.'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.