FDA applicant

SENTINEL CH. SpA

Milan, IT22 decisions2005–20255 recalls

FDA records 22 decisions for SENTINEL CH. SpA (Milan, IT) from 2005 to 2025: 22 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and DCK (C-Reactive Protein, Antigen, Antiserum, And…). Its devices cite 23 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Sentinel Ch. Srl”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided SENTINEL CH. SpA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2019

2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — SENTINEL CH. SpA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like SENTINEL CH. SpA’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 “SENTINEL”

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

Sentinel Medical Technologies, LLC 3 Sentinel Medical, Inc. 1 Sentinel Monitoring Technologies, Ltd. 1 Sentinel 1

SENTINEL CH. SpA

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “SENTINEL”