510(k) Report

FDA applicant

Mabis Healthcare, Inc.

Lake Forest, IL2 decisions1995–19990 recalls

FDA records 2 decisions for Mabis Healthcare, Inc. (Lake Forest, IL) from 1995 to 1999: 2 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and CAF (Nebulizer (Direct Patient Interface)). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Mabis Healthcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mabis Healthcare, 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • CAFNebulizer (Direct Patient Interface)1decision

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K990506Mabis NB-02 Ultrasonic NebulizerMabis Healthcare, Inc. · 19993cite it
  • K942072Mabis Brand and Mabis Customers Private Label BrandMabis Healthcare, Inc. · 19951cites it

What has FDA decided for it lately?

  • K990506Mabis NB-02 Ultrasonic NebulizerMabis Healthcare, Inc. · 1999
  • K942072Mabis Brand and Mabis Customers Private Label BrandMabis Healthcare, Inc. · 1995

All 2 as Mabis Healthcare, Inc. →