# K134037: Premvia

- Pathway: 510(k) (Traditional)
- Applicant: Biotime, Inc.
- Decided: Aug 7, 2014 after 219 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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 K881854 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072113: Integra Flowable Wound Matrix, Model FWD301, Integra Lifesciences Corp. (2007) Summary page 5.

## Indications for use
Premvia is indicated for the management of wounds including: partial thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.

Source page: https://510kreport.com/device/K134037
Methodology: https://510kreport.com/methodology