FDA applicant
Integral Process Sas
FDA records 2 decisions for Integral Process Sas (Conflans Sainte Honorine, FR) from 2010 to 2017: 2 510(k) clearances. Most are in product codes DSA (Cable, Transducer And Electrode, Patient…) and DRX (Electrode, Electrocardiograph). Its devices cite 7 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Integral Process Sas’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
6in 2022
Class I Class II/III not classified
Planning a device like Integral Process Sas’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 “Integral”
FDA records each applicant name separately; these may or may not be the same firm.