510(k) Report

FDA applicant

Ventris Medical

Newport Beach, CA5 decisions2022–20260 recalls

FDA records 5 decisions for Ventris Medical (Newport Beach, CA) from 2022 to 2026: 5 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 57 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 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 Ventris Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12024: 22025: 12026 (partial year): 1
2022high 2 (2024) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Ventris Medical’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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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound4decisions
  • KGNWound Dressing With Animal-Derived Material (S)1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 57 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240458Synthetic Bone PuttyVentris Medical · 20241cites it

What has FDA decided for it lately?

  • K260596Collagen Wound PowderVentris Medical · 2026
  • K250556Porous Biologic ScaffoldVentris Medical · 2025
  • K240765Porous Biologic ScaffoldVentris Medical · 2024
  • K240458Synthetic Bone PuttyVentris Medical · 2024
  • K221644Synthetic Bone PuttyVentris Medical · 2022

All 5 as Ventris Medical →