510(k) Report

FDA applicant

Oasis Medical, Inc.

Glendora, CA17 decisions1991–20221 recall

FDA records 17 decisions for Oasis Medical, Inc. (Glendora, CA) from 1991 to 2022: 17 510(k) clearances. Most are in product codes LZU (Plug, Punctum) and HNO (Keratome, Ac-Powered). Its devices cite 10 predicates, 3 of them its own earlier devices. 1 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, ophthalmic panel, where it files most

How often FDA has decided Oasis Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 12022: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oasis Medical, Inc.’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 “Oasis”

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