510(k) Report

FDA applicant

Linear Health Sciences, LLC

Oklahoma City, OK4 decisions2022–20240 recalls

FDA records 4 decisions for Linear Health Sciences, LLC (Oklahoma City, OK) from 2022 to 2024: 4 510(k) clearances. All are in product code QOI (Intravenous Catheter Force-Activated…). Its devices cite 4 predicates, 3 of them its own earlier devices. 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, general hospital panel, where it files most

How often FDA has decided Linear Health Sciences, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12023: 22024: 1
2022high 2 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Linear Health Sciences, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Linear Health Sciences, 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 “Linear”

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