510(k) · Cleared
ClearedAlgisite M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KMF Bandage, Liquid
Cleared on Dec 10, 1998 as substantially equivalent to K940407 (Calgon Corp., 1994) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1991. 84 later devices descend from it.
- Decided
- Dec 10, 1998
- Review
- 87 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914575 (1991). 2 ancestors in all. 84 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- This deviceK983210 Algisite MSmith & Nephew, Inc. · 1998
- Descendant · cites it directly · 83 of its ownK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- Descendant · 2 generations on · 53 of its ownK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- Descendant · 3 generations on · 25 of its ownK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- Descendant · 3 generations on · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- Descendant · 2 generations on · 16 of its ownK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K002896Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001 · cites it directly83descendants
- K024298Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003 · 2 generations on53descendants
- K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004 · 3 generations on25descendants
- K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · 3 generations on17descendants
- K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| 0 (this device) | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| +1 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| +2 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| +3 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| +3 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| +2 | K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940407 | Kaltogel Wound DressingSummary page 2…Johnson & Johnson Medical Inc. by Les Laboratoires Brothier S.A. Alginate Dressing Nanterre, France KALTOSTAT ® Calgon Vestal Laboratories Wound Dressing St. Louis, MS (K940407) Sorbsan ™ Topical For Dow B. Hickman, Inc. By Steriseal Limited Wound Dressing Worcestershire, England (K914575) Device Descrip… | 1994 |
| * | K914575 | Sorbsan Topical Wound Dressing (Modified)Summary page 2…Calgon Vestal Laboratories Wound Dressing St. Louis, MS (K940407) Sorbsan ™ Topical For Dow B. Hickman, Inc. By Steriseal Limited Wound Dressing Worcestershire, England (K914575) Device Description Algisite M - Calcium Alginate Dressing Technological Characteristics: The Algisite M - Calcium Alginate D… | 1991 |
| * | — | ALGOSTERIL® Alginate Dressing Named without a submission number |
What descends from it? (84)
See all 841 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | 2001 | 83 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K002896 (The Westaim Corp., 2001) has gone furthest, with 83 descendants of its own.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983210 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983210: Algisite M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983210
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026