FDA applicant
Access Scientific, Inc.
FDA records 14 decisions for Access Scientific, Inc. (San Diego, CA) from 2008 to 2019: 14 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 13 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Access Scientific, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Access Scientific, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Access Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Access”
FDA records each applicant name separately; these may or may not be the same firm.