# K071442: Suprasorb a +AG

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Fibres and Materials, Ltd.
- Decided: May 1, 2008 after 344 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914575 (1991). 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)
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002) Summary page 1.
- K041316: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2004) Summary page 1.

## Most influential descendants
- K183208: Suprasorb A + Ag “R” (2019), 0 descendants of its own

## Recalls of this device
- Oct 14, 2015 · Class II · Z-0293-2016: The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal

## Indications for use
Suprasorb® A -Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds 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/K071442
Methodology: https://510kreport.com/methodology