Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Access Scientific, LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
262 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Cathe | Access Scientific, LLC | 2019-07-25 | 262 | 0 |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter m | Access Scientific, LLC | 2018-09-26 | 104 | 0 |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC | 2018-09-18 | 29 | 0 |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Cathe | Access Scientific, LLC | 2016-11-17 | 90 | 0 |
| K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | Access Scientific, LLC | 2013-09-04 | 134 | 0 |
| K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHE | Access Scientific, LLC | 2013-06-07 | 31 | 1 |
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