Strato Medical Corp.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Strato Medical Corp.” (first 1984, latest 1995), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 113 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 | 27 | 27 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 8 | 8 |
| FRN | Pump, Infusion | 6 | 6 |
| FPA | Set, Administration, Intravascular | 4 | 4 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 1 | 0 |
Review panels
Most recent Strato Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945956 | STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS | LJS | 1995-06-06 | 182 |
| K946250 | STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS | LJS | 1995-05-02 | 130 |
| K942848 | STRATO MEDICAL LIFEPORT LPS 7515 | LJT | 1995-02-01 | 230 |
| K934518 | STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM | LJT | 1995-01-27 | 497 |
| K932509 | STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT | LJT | 1994-01-07 | 227 |
| K933884 | STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM | LJS | 1993-12-30 | 142 |
| K924851 | STRATO MEDICAL SINGLE LUMEN VALVED CATHETER | LJS | 1993-12-13 | 441 |
| K924677 | STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH | LJS | 1993-07-30 | 317 |
| K921751 | INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER | LJS | 1993-07-07 | 450 |
| K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 | LJT | 1993-07-07 | 590 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820002 | PMA | CRYOMAX(TM) | 1983-01-31 |
Recalls
openFDA lists no recalls under a recalling firm named Strato Medical 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Strato Medical Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Strato Medical Corp.?
FDA lists 45 510(k) clearances under the applicant name “Strato Medical Corp.” (first 1984, latest 1995), plus 1 PMA decision, across 5 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 Strato Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Strato Medical Corp. is 113 days.
Which FDA product codes appear under Strato Medical Corp.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 27); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 8); FRN (Pump, Infusion, 6).
Next steps
- See all 45 Strato Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Strato Medical 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, 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.