510(k) · Cleared
ClearedKA01 Chitosan Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan United Medical Technologies, Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jan 26, 2015 as substantially equivalent to K070175 (Medtrade Products, Ltd., 2007) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- Jan 26, 2015
- Review
- 87 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914575 (1991). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 5 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 4 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 3 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 2 generations backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- 1 generation backK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- This deviceK143124 KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK212766 Maxiocel Chitosan Wound DressingAdvamedica, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK172010 gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −5 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −4 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −3 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −2 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| −1 | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| 0 (this device) | K143124 | KA01 Chitosan Wound Dressing | Foshan United Medical Technologies, Ltd. | 2015 | — |
| +1 | K212766 | Maxiocel Chitosan Wound Dressing | Advamedica, Inc. | 2023 | — |
| +1 | K172010 | gel-e Bandage | Gel-E, Inc. (Formerly Remedium Technologies, Inc.) | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K070175 | Aquanova Super-Absorbent Gelling Dressing, OtcSummary page 5…FRO Device Class: Unclassified Classification Panel: General and Plastic Surgery 5. Predicate Devices Primary: K070175 MedTrade Products Aquanova Super-Absorbent Dressing Secondary: K063271 Convatec Aquacel Hydrofibre Wound… | 2007 |
| * | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Summary page 5…Panel: General and Plastic Surgery 5. Predicate Devices Primary: K070175 MedTrade Products Aquanova Super-Absorbent Dressing Secondary: K063271 Convatec Aquacel Hydrofibre Wound Dressing… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K212766 (Advamedica, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070175.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
The KAO1 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for the management of®
Pressure sores
Diabetic ulcers
Leg ulcers
Donor sites and Graft sites
Surgical wounds
Skin abrasions and lacerations
1st and 2nd degree burns
Trauma wounds
The KAO01 Chitosan Wound Dressing may be used for the management of:
Minor cuts
Minor scalds and 1st degree burns
Abrasions
Lacerations
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/K143124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143124: KA01 Chitosan Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143124
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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