# K980989: 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: May 27, 1998 after 72 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953781 (1995). 1 ancestor in all.
37 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953781: Innovative Technologies Calcium Alginate Wound Dressings, Innovative Technologies, Ltd. (1995) Summary page 1.

## Most influential descendants
- K010933: Seal-on Topical Hempstatic Powder Spray (2002), 35 descendants of its own
- K024107: Femostop Femoral Compression System (2002), 23 descendants of its own
- K040730: Vascular Solutions D-Stat Clamp Hemostatic Clamp (2004), 17 descendants of its own
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own
- K053300: Syvekexcel (2006), 14 descendants of its own

## Indications for use
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

Source page: https://510kreport.com/device/K980989
Methodology: https://510kreport.com/methodology