Sunscope Intl., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sunscope Intl., Inc.” (first 1991, latest 2000), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 134 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
Review panels
- Cardiovascular (6)
- General Hospital (1)
Most recent Sunscope Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | FOZ | 2000-11-17 | 71 |
| K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | DRS | 1999-02-05 | 134 |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | DXE | 1998-09-04 | 354 |
| K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | 1998-08-20 | 94 |
| K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | DRS | 1998-07-17 | 60 |
| K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | DQO | 1991-10-23 | 189 |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | KRB | 1991-09-27 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Sunscope Intl., 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 Sunscope Intl., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Sunscope Intl., Inc.” (first 1991, latest 2000), 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 Sunscope Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sunscope Intl., Inc. is 134 days.
Which FDA product codes appear under Sunscope Intl., Inc.?
The most frequent FDA product codes under this applicant name are DRS (Transducer, Blood-Pressure, Extravascular, 3); DQO (Catheter, Intravascular, Diagnostic, 1); DXE (Catheter, Embolectomy, 1).
Next steps
- See all 7 Sunscope Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRS, Sunscope Intl., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.