# K022995: Collatek Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Biocore Medical Technologies, Inc.
- Decided: Dec 2, 2002 after 84 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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 K973688 (1997). 5 ancestors in all.
106 later devices descend from it; 3 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991202: Modification to Woun'dres, Coloplast Corp. (1999) Summary page 1.
- K983362: NU-Gel * Wound Dressing, Johnson & Johnson Medical, Inc. (1998) Summary page 1.

## Most influential descendants
- K040019: Silverseal (2004), 97 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own

## Indications for use
Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as: First and second degree bums Severe sunburns Superficial injuries, cuts, abrasions and surgical wounds Collatek Hydrogel may be used under clinical guidance in the management of the followink types of dry, light and moderately exudating partial and full thickness wounds: Pressure (stage I-IV) and venous stasis ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Donor sites and grafts

Source page: https://510kreport.com/device/K022995
Methodology: https://510kreport.com/methodology