Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunscope Intl., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
354 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | Sunscope Intl., Inc. | 2000-11-17 | 71 | 0 |
| K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | Sunscope Intl., Inc. | 1999-02-05 | 134 | 0 |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | Sunscope Intl., Inc. | 1998-09-04 | 354 | 0 |
| K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | Sunscope Intl., Inc. | 1998-08-20 | 94 | 0 |
| K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | Sunscope Intl., Inc. | 1998-07-17 | 60 | 0 |
| K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | Sunscope Intl., Inc. | 1991-10-23 | 189 | 0 |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sunscope Intl., Inc. | 1991-09-27 | 134 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda