# K173844: Titan Ag 200

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Fibres and Materials, Ltd.
- Decided: Aug 9, 2018 after 233 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 K914604 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec, Inc. (2012) Summary page 4.

## Most influential descendants
- K222740: Venus Ag 120, 160, 200  2x2 inch, Venus Ag 120, 160, 200  4x4 inch, Venus Ag 120, 160, 200  4x5 inch, Venus Ag 120, 160, 200  6x6 inch,Venus Ag 120, 160, 200  1x18 inch (2024), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, Titan Ag 200 may be used for the management of: • Wounds with moderate to heavy exudate. • Partial thickness burns. • Leg ulcers, pressure ulcers and diabetic ulcers. • Surgical wounds (e.g. post-operative, wounds left to heal by secondary intent and donor/graft sites). • Traumatic wounds (e.g. abrasions and lacerations). • Wounds prone to bleeding such as wounds that have been mechanically or surgically debrided or donor sites.

Source page: https://510kreport.com/device/K173844
Methodology: https://510kreport.com/methodology