510(k) Report

FDA applicant

Fadasis Medical, Inc.

Middleton, WI2 decisions2001–20010 recalls

FDA records 2 decisions for Fadasis Medical, Inc. (Middleton, WI) in 2001: 2 510(k) clearances. All are in product code MRO (Apparatus, Nitric Oxide, Backup Delivery). Its devices cite 1 predicate, 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Fadasis Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fadasis 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?

  • MROApparatus, Nitric Oxide, Backup Delivery2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 20012cite it
  • K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 20011cites it

What has FDA decided for it lately?

  • K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  • K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001

All 2 as Fadasis Medical, Inc. →