FDA applicant

Acuity Surgical Devices, LLC

Irving, TX8 decisions2021–20250 recalls

FDA records 8 decisions for Acuity Surgical Devices, LLC (Irving, TX) from 2021 to 2025: 8 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 9 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, orthopedic panel, where it files most

How often FDA has decided Acuity Surgical Devices, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2021high 3 (2025) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

Planning a device like Acuity Surgical Devices, 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 “Acuity”

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

Acuity Polymers, Inc. 11

Acuity Surgical Devices, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Acuity”