510(k) · Cleared
ClearedMaxiocel Chitosan Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advamedica, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 24, 2023 as substantially equivalent to K143124 (Foshan United Medical Technologies, Ltd., 2015) and 1 other predicate after a 723-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Aug 24, 2023
- Review
- 723 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K914575 (1991). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 6 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 5 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 4 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 3 generations backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- 2 generations backK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- 1 generation backK143124 KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd. · 2015
- This deviceK212766 Maxiocel Chitosan Wound DressingAdvamedica, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −6 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −5 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −4 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −3 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| −2 | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| −1 | K143124 | KA01 Chitosan Wound Dressing | Foshan United Medical Technologies, Ltd. | 2015 | — |
| 0 (this device) | K212766 | Maxiocel Chitosan Wound Dressing | Advamedica, Inc. | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K143124 | KA01 Chitosan Wound DressingSummary page 6…FRO FRO Panel General & Plastic Surgery General & Plastic Surgery 510(k) Number K143124 K070175 4. IDENTIFICATION OF REFERENCE DEVICE Table 2: Refer… | 2015 |
| * | K070175 | Aquanova Super-Absorbent Gelling Dressing, OtcSummary page 6…FRO Panel General & Plastic Surgery General & Plastic Surgery 510(k) Number K143124 K070175 4. IDENTIFICATION OF REFERENCE DEVICE Table 2: Reference device details… | 2007 |
| † | K202830 | Axiostat Patch | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K143124.
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. 2023, 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 Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration.
Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds:
• Pressure sores
• Diabetic ulcers
• Leg ulcers
• Donor sites and graft sites
• Surgical wounds
• Skin abrasions and lacerations
• 1st and 2nd degree bums
• Trauma wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212766 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212766: Maxiocel Chitosan Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212766
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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