# 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

- Pathway: 510(k) (Traditional)
- Applicant: Speciality Fibres and Materials, Ltd.
- Decided: Oct 21, 2024 after 773 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: 6 generations back to K914604 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173844: Titan Ag 200, Specialty Fibres and Materials, Ltd. (2018) Summary page 5.
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec, Inc. (2012) Summary page 5.
- K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec Limited (2018) Summary page 5.
- K162508: KerraCel Ag Gelling Fiber Silver Dressing, Exciton Technologies, Inc. (2017) Summary page 5.

## Indications for use
Under the supervision of a healthcare professional, Venus Ag 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 that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites. The product is for a single use only.

Source page: https://510kreport.com/device/K222740
Methodology: https://510kreport.com/methodology