510(k) · Cleared
ClearedCoreleader Colla-Pad Model CS 03030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coreleader Biotech Co., Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on May 20, 2011 as substantially equivalent to K072113 (Integra Lifesciences Corp., 2007) and 2 other predicates after a 228-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- May 20, 2011
- Review
- 228 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K881854 (1988). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 2 generations backK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
- 1 generation backK072113 Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 2007 · Recalled
- This deviceK102946 Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −2 | K022127 | Avagen Wound Dressing | Integra Lifesciences Corp. | 2002 | — |
| −1 | K072113 | Integra Flowable Wound Matrix, Model FWD301 | Integra Lifesciences Corp. | 2007 | 1 |
| 0 (this device) | K102946 | Coreleader Colla-Pad Model CS 03030 | Coreleader Biotech Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K072113 | Integra Flowable Wound Matrix, Model FWD301Summary page 1…Collagen Wound Dressing Classification: Unclassified Classification Name: Topical Wound Dressing Pad Predicate Device: INTEGRA LIIFESCIENCES CORP., K072113, INTEGRA FLOWABLE WOUND MATRIX. INTEGRA LWESCIENCES CORP., K08163 5,… | 2007 |
| * | K081635 | Integra Meshed Bilayer Wound MatrixSummary page 1…Pad Predicate Device: INTEGRA LIIFESCIENCES CORP., K072113, INTEGRA FLOWABLE WOUND MATRIX. INTEGRA LWESCIENCES CORP., K08163 5, INTEGRA MESHED BRLAYER WOUND MATRIX. MAXIGEN BIOTEQ INC., K1 00927, SurgiAid Colla… | 2008 |
| * | K100927 | Surgiaid Cleared while this submission was under review Summary page 1…TRIX. INTEGRA LWESCIENCES CORP., K08163 5, INTEGRA MESHED BRLAYER WOUND MATRIX. MAXIGEN BIOTEQ INC., K1 00927, SurgiAid Collagen Wound Dressing Device Description: Coreleader Colla-Pad is comprised of a porous ma… | 2011 |
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 23 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 4 other devices also cite its predicate K072113.
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. 2011, 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?
Coreleader Colla-Pad Wound Dressing is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled! undermined wounds, surgical wounds, (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102946: Coreleader Colla-Pad Model CS 03030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102946
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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