FDA applicant

Opti Medical Systems, Inc.

Roswell, GA3 decisions2011–20211 recall

FDA records 3 decisions for Opti Medical Systems, Inc. (Roswell, GA) from 2011 to 2021: 3 510(k) clearances. All are in product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). Its devices cite 4 predicates, 1 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2021

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2012

2011high 1 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Opti Medical Systems, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Opti Medical Systems, 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 “Opti”

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

Opti-Centre Laboratories 6 Opti-Max 6 Opti-Ray, Inc. 2 Opti-Med Electronics 1

Opti Medical Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Opti”