510(k) Report

FDA applicant

Airgas Therapeutics, LLC

Plumsteadville4 decisions1993–20250 recalls

FDA records 4 decisions for Airgas Therapeutics, LLC (Plumsteadville) from 1993 to 2025: 2 510(k) clearances and 2 original PMA approvals. Most are in product codes LPO (Gases Used Within Eye To Place Pressure On…) and MRN (Apparatus, Nitric Oxide Delivery). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Airgas Therapeutics”.

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

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

How often FDA has decided Airgas Therapeutics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12025: 1
2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Airgas Therapeutics, 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 “Airgas”

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