# K040283: Biopad

- Pathway: 510(k) (Traditional)
- Applicant: Euroresearch Srl
- Decided: Jul 22, 2005 after 532 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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: 2 generations back to K881854 (1988). 5 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 5.
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 5.

## Cited in the summary but kept off the family tree
- K993490: Quickstrip One Step Opiates Test, Syntron Bioresearch, Inc. (1999). Our reading of the summary gave K993490, FDA’s number for Quickstrip One Step Opiates Test (Syntron Bioresearch, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SIS Wound Dressing H”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K061494: Dermadapt Wound Dressing (2006), 26 descendants of its own
- K071425: Unite Biomatrix (2007), 25 descendants of its own
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K082103: LTM Wound Dressing (2008), 7 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own

## Indications for use
BIOPAD® is a collagen wound dressing intended for the control of minor bleeding, and for the local management of moderately to heavy exuding wounds including: pressure ulcers, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, surgical and traumatic wounds, donor sites and other bleeding surface wounds dehisced surgical incisions draining wounds lacerations podiatric post-laser surgery The product is supplied sterile and for one-time-use only.

Source page: https://510kreport.com/device/K040283
Methodology: https://510kreport.com/methodology