# K983210: Algisite M

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 10, 1998 after 87 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 K914575 (1991). 2 ancestors in all.
84 later devices descend from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940407: Kaltogel Wound Dressing, Calgon Corp. (1994) Summary page 2.
- K914575: Sorbsan Topical Wound Dressing (Modified), Dow B. Hickam, Inc. (1991) Summary page 2.
- (no number) ALGOSTERIL® Alginate Dressing: named in the summary without a submission number

## Most influential descendants
- K002896: Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing (2001), 83 descendants of its own
- K024298: Antimicrobial Alginate Dressing (2003), 53 descendants of its own
- K032986: Clo-Surplusp.a.D. (2004), 25 descendants of its own
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) (2004), 17 descendants of its own
- K041316: Antimicrobial Alginate Dressing (2004), 16 descendants of its own

## Indications for use
For OTC applications, Algisite M may be used for the management of minor conditions such as: * Lacerations * Abrasions * Skin Tears * Minor Burns Under the care of a healthcare professional, Algisite M may be used for the management of full and partial thickness wounds including: Leg Ulcers Pressure Ulcers Diabetic Foot Ulcers Surgical Wounds

Source page: https://510kreport.com/device/K983210
Methodology: https://510kreport.com/methodology