FDA applicant
Persyst Development Corporation
FDA records 11 decisions for Persyst Development Corporation (Solana Beach, CA) from 1998 to 2025: 11 510(k) clearances. Most are in product codes OMB (Automatic Event Detection Software For…) and GXZ (Electrode, Needle). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Persyst Development Corp.”, “Persyst Development, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Persyst Development Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Persyst Development Corporation’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 “Persyst”
FDA records each applicant name separately; these may or may not be the same firm.