# K093544: Tropazone CR

- Pathway: 510(k) (Traditional)
- Applicant: Midlothian Laboratories
- Decided: Feb 16, 2010 after 91 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961758 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964240: Biafine Wound Dressing Emulsion, Medix Pharmaceuticals Americas, Inc. (1997) Summary page 1.
- K090337: Tropazone Lotion, Midlothian Laboratories (2009) Summary page 1.
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.
- K073246: Zenieva, Gorbec Pharmaceutical Services, Inc. (2008) Summary page 1.

## Most influential descendants
- K113807: Dexeryl Cream (2012), 0 descendants of its own

## Indications for use
Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis.

Source page: https://510kreport.com/device/K093544
Methodology: https://510kreport.com/methodology