Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Access Scientific, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
306 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | Access Scientific, Inc. | 2012-07-27 | 43 | 1 |
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL C | Access Scientific, Inc. | 2011-07-15 | 56 | 1 |
| K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | Access Scientific, Inc. | 2011-06-22 | 61 | 0 |
| K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATH | Access Scientific, Inc. | 2011-03-22 | 306 | 0 |
| K101150 | PICC WAND PEELABLE SAFETY INTRODUCER | Access Scientific, Inc. | 2010-08-13 | 112 | 0 |
| K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER | Access Scientific, Inc. | 2010-01-20 | 113 | 0 |
| K090372 | THE WAND MICROACCESS SAFETY INTRODUCER | Access Scientific, Inc. | 2009-03-30 | 45 | 0 |
| K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, | Access Scientific, Inc. | 2008-12-04 | 170 | 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