# K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Andover Healthcare, Inc.
- Decided: Oct 30, 2009 after 372 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 K914579 (1992). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050649: Silverseal Contacting Wound Dressing with X-Static, Noble Fiber Technologies, Inc. (2005) Summary page 3.
- K050030: Acticoat Moisture Control Dressing, Smith & Nephew, Inc. (2005) Summary page 1.
- K061554: Mepilex AG Absorbent Silicone-Coated Dressing, Molnlycke Health Care (2007) Summary page 1.
- K031307: Ferris Polymem Silver Wound Dressing, Ferris Mfg. Corp. (2003) Summary page 3.

## Most influential descendants
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own
- K242856: LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (2024), 0 descendants of its own
- K223359: LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (2023), 0 descendants of its own

## Indications for use
Under the supervision of a health care professional, CoFlex - X AFD® and the CoFlex - X AFD® Pad contact wound dressings are indicated for use in light to heavy exuding partial and full thickness wounds, including decubitus and diabetic ulcers, 1st and 2nd degree burns, and donor sites. These dressings may also be used over debrided and partial thickness wounds. For over the-counter use, PowerFlex NL - X AFD® and CoFlex - X AFD® First Aid contact wound dressings are, indicated for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Source page: https://510kreport.com/device/K083133
Methodology: https://510kreport.com/methodology