510(k) Report

FDA applicant

Anuncia Medical, Inc.

Scottsdale, AZ2 decisions2022–20220 recalls

FDA records 2 decisions for Anuncia Medical, Inc. (Scottsdale, AZ) in 2022: 2 510(k) clearances. All are in product code JXG (Shunt, Central Nervous System And Components). Its devices cite 2 predicates, 1 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, neurology panel, where it files most

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

FDA decisions per year

2in 2022

2022: 2
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Anuncia Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221918ReFlow System MiniAnuncia Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K223603Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. · 2022
  • K221918ReFlow System MiniAnuncia Medical, Inc. · 2022

All 2 as Anuncia Medical, Inc. →