510(k) · Cleared
ClearedCollexa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innocoll Pharmaceuticals · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 28, 2010 as substantially equivalent to K092805 (Innocoll Pharmaceuticals, 2010) after a 241-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Oct 28, 2010
- Review
- 241 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K910944 (1991). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK910944 MedifilBiocore · 1991
- 6 generations backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- 5 generations backK040211 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 4 generations backK040558 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 3 generations backK061746 Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006
- 2 generations backK081782 CollievaInnocoll Pharmaceuticals · 2008
- 1 generation backK092805 Collagen SpongeInnocoll Pharmaceuticals · 2010
- This deviceK100574 CollexaInnocoll Pharmaceuticals · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910944 | Medifil | Biocore | 1991 | — |
| −6 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| −5 | K040211 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −4 | K040558 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −3 | K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | Innocoll Pharmaceuticals | 2006 | — |
| −2 | K081782 | Collieva | Innocoll Pharmaceuticals | 2008 | — |
| −1 | K092805 | Collagen Sponge | Innocoll Pharmaceuticals | 2010 | — |
| 0 (this device) | K100574 | Collexa | Innocoll Pharmaceuticals | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K101299 | FDA’s K101299 is Accu-Chek Aviva Plus Blood Glucose Monitoring System Our reading of the summary gave K101299, which FDA decided on Sep 21, 2011, after this device was decided (Oct 28, 2010), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1…6. Statement of Substantial Equivalence: Collexa is substantially equivalent in materials of construction and intended use to Collatek Foam (K1012997) and Collagen Sponge (K092805). Page 5 -… | 2011 |
| * | K092805 | Collagen SpongeSummary page 1…tial Equivalence: Collexa is substantially equivalent in materials of construction and intended use to Collatek Foam (K1012997) and Collagen Sponge (K092805). Page 5 - 2 7. Intended Use Collexa m… | 2010 |
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 19 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K092805.
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. 2010, 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?
Collexa may be used for the management of wounds including:.
* Diabetic ulcers
* Venous ulcers
* Pressure ulcers
* Ulcers caused by mixed vascular etiologies
* Full-thickness & partial thickness wounds
* Abrasions
* Traumatic wounds
* 1st and 2nd degree burns
Dehisced surgical wounds
* Exuding wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100574: Collexa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100574
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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