# Qualis, Inc.

- Location (FDA's records): Des Moines, IA
- FDA decisions: 6 (1997–2005): 6 510(k) clearances
- Product codes: NUC (3), HIS (2), KMJ (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Personal Products Co., Div. of Mcneil Ppc, Inc.: 2 (https://510kreport.com/company/personal-products-co-div-of-mcneil-ppc)
- Personal Products Company, Div. of Mcneil-Ppc, Inc.: 2 (https://510kreport.com/company/personal-products-company-div-of-mcneil-ppc)
- Ortho Pharmaceutical Corp.: 1 (https://510kreport.com/company/ortho-pharmaceutical)
- Biofilm, Inc.: 1 (https://510kreport.com/company/biofilm)

## Firms that cite its devices most
- Cst Medical Limited: 1 (https://510kreport.com/company/cst-medical)
- Westridge Laboratories, Inc.: 1 (https://510kreport.com/company/westridge-laboratories)

## Its most-cited devices
- K041129: Personal Lubricating Gel (2004), cited by 2

## Recent decisions
- K050211: Personal Warming Gel (Mar 17, 2005)
- K050212: Personal Warming Jelly (Mar 17, 2005)
- K041129: Personal Lubricating Gel (Sep 24, 2004)
- K040085: Personal Warming Lubricant (Apr 20, 2004)
- K973780: Personal Lubricating Liquid (Nov 26, 1997)
- K973557: Lubriglide (Oct 10, 1997)

Source page: https://510kreport.com/company/qualis