# K140367: Architect PX Extracellular Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Harbor Medtech, Inc.
- Decided: Sep 12, 2014 after 210 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: 6 generations back to K881854 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122502: Bridge Extracellular Collegen Matrix, Harbor Medtech, Inc. (2013) Summary page 6.

## Indications for use
The Harbor MedTech Architect™ Px Extracellular Collagen Matrix is indicated for the local management of moderately to heavy exuding wounds, including: Partial and full thickness wounds, Draining wounds, Pressure sores/ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)

Source page: https://510kreport.com/device/K140367
Methodology: https://510kreport.com/methodology