FDA applicant
Std Med, Inc.
FDA records 2 decisions for Std Med, Inc. (Ayer, MA) from 2007 to 2008: 2 510(k) clearances. All are in product code LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Std Med, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2007high 1 (2007) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Std Med, 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) Report