# K183208: Suprasorb A + Ag “R”

- Pathway: 510(k) (Traditional)
- Applicant: Speciality Fibres and Materials, Ltd.
- Decided: Aug 15, 2019 after 269 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 K914575 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071442: Suprasorb a +AG, Specialty Fibres and Materials, Ltd. (2008) Summary page 4.

## Indications for use
Suprasorb® A +Ag “R” can be used for the management of wounds, in adult patients only, which are: • Moderately and heavily exuding • Superficial or • Deep Such as: • Pressure sores • Arterial Ulcers • Venous lower leg ulcers • Diabetic ulcers • Post-operative wounds

Source page: https://510kreport.com/device/K183208
Methodology: https://510kreport.com/methodology