FDA applicant

Sentinel

Indianapolis, IN1 decision1991–19910 recalls

FDA records 1 decision for Sentinel (Indianapolis, IN) in 1991: 1 510(k) clearance. All are in product code DQA (Oximeter). No recall is 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 Sentinel’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sentinel since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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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 CH. SpA 22 Sentinel Medical Technologies, LLC 3 Sentinel Medical, Inc. 1 Sentinel Monitoring Technologies, Ltd. 1

Sentinel

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sentinel”