FDA applicant
Presym, Inc.
FDA records 1 decision for Presym, Inc. (Pleasanton, CA) in 2007: 1 510(k) clearance. All are in product code DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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 Presym, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Presym, 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