510(k) Report

FDA applicant

Integral Process Sas

Conflans Sainte Honorine, FR2 decisions2010–20176 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Integral Process Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2010: 12017: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

6in 2022

2022: 6
2010high 6 (2022) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Integral Process Sas by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Integral”

FDA records each applicant name separately; these may or may not be the same firm.