Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Access Vascular, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
266 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire | Access Vascular, Inc. | 2025-08-01 | 266 | 0 |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); | Access Vascular, Inc. | 2025-07-01 | 74 | 0 |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (7000610 | Access Vascular, Inc. | 2025-03-27 | 86 | 0 |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire | Access Vascular, Inc. | 2025-01-17 | 28 | 0 |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022-12-07 | 266 | 0 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | 2022-05-04 | 177 | 2 |
| K203069 | HydroMID | Access Vascular, Inc. | 2021-02-08 | 122 | 3 |
| K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | 2020-02-20 | 114 | 4 |
| K172885 | HydroPICC | Access Vascular, Inc. | 2018-02-20 | 152 | 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