# K980132: Phytacare Alginate Hydrogel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Phytatek Laboratories, Inc.
- Decided: Jun 26, 1998 after 162 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
No predicates in its family tree.
98 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CarraGauze® - Carrasyn® Hydrogel Wound Dressing, Carrington Laboratories: named in the summary without a submission number
- (no number) Curasol™ Gel Wound Dressing, Healthpoint Medical: named in the summary without a submission number
- (no number) DermaGran™ Hydrophilic Wound Dressing, Derma Sciences: named in the summary without a submission number
- (no number) TransiGel™ Conformable Gel Dressing, Smith & Nephew United, Inc.: named in the summary without a submission number
- (no number) Biolex™ Impregnated Wound Dressing, C.R. Bard, Inc.: named in the summary without a submission number
- (no number) Saf-Gel®, Hydrating Dermal Wound Dressing with Alginate, ConvaTec: named in the summary without a submission number

## 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
For the management of: Diabetic Ulcers, Foot Ulcers, 1st and 2nd Degree Burns, Pressure Ulcers Stages I-IV, Cuts, and Abrasions.

Source page: https://510kreport.com/device/K980132
Methodology: https://510kreport.com/methodology