510(k) · Cleared
ClearedKeraStat (R) Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keranetics, LLC · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 2, 2017 as substantially equivalent to K080949 (Keratec Limited, 2009) after a 245-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Jun 2, 2017
- Review
- 245 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881854 (1988). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK014129 Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002
- 2 generations backK033523 Collagen-Orc Antimicrobial MatrixJohnson & Johnson Medical, Ltd. · 2004
- 1 generation backK080949 Keratec Wound DressingsKeratec Limited · 2009
- This deviceK162759 KeraStat (R) GelKeranetics, LLC · 2017
- Descendant · cites it directly · 0 of its ownK192386 KeraStat CreamKeranetics · 2020
Most influential descendants
Showing 1 of 1 · See all- K192386KeraStat CreamKeranetics · 2020 · cites it directly0descendants
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 | K014129 | Promogran Matrix Wound Dressing | Johnson & Johnson Medical, Ltd. | 2002 | — |
| −2 | K033523 | Collagen-Orc Antimicrobial Matrix | Johnson & Johnson Medical, Ltd. | 2004 | — |
| −1 | K080949 | Keratec Wound Dressings | Keratec Limited | 2009 | — |
| 0 (this device) | K162759 | KeraStat (R) Gel | Keranetics, LLC | 2017 | — |
| +1 | K192386 | KeraStat Cream | Keranetics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K080949 | Keratec Wound DressingsSummary page 4…Dressing, Wound, Collagen Predicate Device(s): Keratec Wound Dressings Keratec Limited K080949 Cleared on February 11, 2009 Device Description: KeraStat® Gel is a sterile, non-impla… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192386 | KeraStat Cream | 2020 | 0 |
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 29 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K192386 (Keranetics, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080949.
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. 2017, 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?
KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat® Gel is indicated for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, abrasions, and incisions/surgical wounds. Under the direction of a healthcare practitioner, KeraStat® Gel also may be used in the management of dry, light, and moderately…
Read the full statement (109 words)
KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat® Gel is indicated
for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns,
severe sunburns, superficial injuries, cuts, abrasions, and incisions/surgical wounds. Under the direction of a healthcare
practitioner, KeraStat® Gel also may be used in the management of dry, light, and moderately exuding partial thickness
wounds including: pressure (stage I-II) ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic
ulcers, donor sites, and grafts.
KeraStat® Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162759: KeraStat (R) Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162759
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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