510(k) · Cleared
ClearedKeratec Wound Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keratec Limited · FRO Dressing, Wound, Drug
Cleared on Feb 11, 2009 as substantially equivalent to K061711 (Cook Biotech, Inc., 2006) and 3 other predicates after a 314-day review. Its family tree reaches back 4 generations to 1988. 3 later devices descend from it.
- Decided
- Feb 11, 2009
- Review
- 314 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K881854 (1988). 15 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 3 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK014129 Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002
- 1 generation backK033523 Collagen-Orc Antimicrobial MatrixJohnson & Johnson Medical, Ltd. · 2004
- This deviceK080949 Keratec Wound DressingsKeratec Limited · 2009
- Descendant · cites it directly · 1 of its ownK162759 KeraStat (R) GelKeranetics, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK192386 KeraStat CreamKeranetics · 2020
- Descendant · cites it directly · 0 of its ownK182010 ProgenaMatrixCell Constructs I, LLC · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −3 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K014129 | Promogran Matrix Wound Dressing | Johnson & Johnson Medical, Ltd. | 2002 | — |
| −1 | K033523 | Collagen-Orc Antimicrobial Matrix | Johnson & Johnson Medical, Ltd. | 2004 | — |
| 0 (this device) | K080949 | Keratec Wound Dressings | Keratec Limited | 2009 | — |
| +1 | K162759 | KeraStat (R) Gel | Keranetics, LLC | 2017 | — |
| +2 | K192386 | KeraStat Cream | Keranetics | 2020 | — |
| +1 | K182010 | ProgenaMatrix | Cell Constructs I, LLC | 2019 | 1 |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K061711 | Oasis Wound MatrixSummary page 1…on/Usual Name: Wound Dressings Classification Name: Wound and Burn Dressings 3. PREDICATE DEVICES * Oasis Wound Matrix by Healthpoint (K06171 1) * Biocore Medical Technologies inc. MediFil Collatek Hydrogel (K022995) *Biocore Medical Technologies Collatek Foa… | 2006 |
| * | K022995 | Collatek HydrogelSummary page 1…and Burn Dressings 3. PREDICATE DEVICES * Oasis Wound Matrix by Healthpoint (K06171 1) * Biocore Medical Technologies inc. MediFil Collatek Hydrogel (K022995) *Biocore Medical Technologies Collatek Foamn (KO 12997) * Johnson & Johnson Collagen ORC Antimicrobial Matrix (K03… | 2002 |
| * | K012997 | Collatek Foam | 2001 |
| * | K033523 | Collagen-Orc Antimicrobial MatrixSummary page 1…ies inc. MediFil Collatek Hydrogel (K022995) *Biocore Medical Technologies Collatek Foamn (KO 12997) * Johnson & Johnson Collagen ORC Antimicrobial Matrix (K033523) 4. DEVICE DESCRIPTION The Keratec Keragel, Kerafoam and Keraderm Wound Dressings (Keratec Wound Dressings) are de… | 2004 |
What descends from it? (3)
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 21 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K162759 (Keranetics, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K061711.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as: · first and second degree burns * severe sunburns * superficial injuries, cuts, abrasions and surgical wounds The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds: *…
Read the full statement (134 words)
The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended
for the management of partial and full thickness wounds such as:
· first and second degree burns
* severe sunburns
* superficial injuries, cuts, abrasions and surgical wounds
The Keratec Wound Dressings may also be used under guidance of a health
care professional in the management of the following types of dry, light and
moderately exudating partial and full thickness wounds:
* Pressure (stage I-IV) and venous stasis ulcers
· Ulcers caused by mixed vascular etiologies
· Diabetic ulcers
* Donor sites and grafts
Keragel is intended for dry to moderately exuding wounds, Keraderm for low to
highly exuding wounds and Kerafoam for moderately exuding wounds to highly
exuding wounds.
The Keratec Wound Dressings are not intended to be used on third degree
burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080949: Keratec Wound Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080949
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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