510(k) Report

FDA applicant

Sentinel Medical Technologies, LLC

Jacksonville, FL3 decisions2021–20260 recalls

FDA records 3 decisions for Sentinel Medical Technologies, LLC (Jacksonville, FL) from 2021 to 2026: 3 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and PHU (Intra-Abdominal Pressure Monitoring Device). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sentinel Medical Technologies,”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Sentinel Medical Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12024: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Sentinel Medical Technologies, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sentinel Medical Technologies, LLC’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.