510(k) Report

FDA applicant

Qualis, Inc.

Des Moines, IA6 decisions1997–20050 recalls

FDA records 6 decisions for Qualis, Inc. (Des Moines, IA) from 1997 to 2005: 6 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and HIS (Condom). Its devices cite 6 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Qualis, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Qualis, 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?

  • NUCLubricant, Personal3decisions
  • HISCondom2decisions
  • KMJLubricant, Patient1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K041129Personal Lubricating GelQualis, Inc. · 20042cite it

What has FDA decided for it lately?

  • K050211Personal Warming GelQualis, Inc. · 2005
  • K050212Personal Warming JellyQualis, Inc. · 2005
  • K041129Personal Lubricating GelQualis, Inc. · 2004
  • K040085Personal Warming LubricantQualis, Inc. · 2004
  • K973780Personal Lubricating LiquidQualis, Inc. · 1997
  • K973557LubriglideQualis, Inc. · 1997

All 6 as Qualis, Inc. →