510(k) · Cleared
ClearedEnluxtra Humifiber Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Basf Venture Capital America, Inc. · FRO Dressing, Wound, Drug
Cleared on Aug 28, 2012 as substantially equivalent to K092351 (Polyremedy, Inc., 2010) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Aug 28, 2012
- Review
- 28 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933495 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK933495 MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)Marketing Professionals IN Medicine, Inc. · 1994
- 1 generation backK981150 Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998
- This deviceK122297 Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933495 | MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads) | Marketing Professionals IN Medicine, Inc. | 1994 | — |
| −1 | K981150 | Solosite Gel Conformable Dressing | Smith & Nephew, Inc. | 1998 | — |
| 0 (this device) | K122297 | Enluxtra Humifiber Wound Dressing | Basf Venture Capital America, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K092351 | Poly Fit + Absorbing and High Absorbing Antimicrobial DressingsSummary page 1…Enluxtra T m Humifiber TM Wound Dressing, Class 1, 510k Exempt, Product Code NAC PolyFIT+ Absorbing Dressings (K092351), Unclassified SoloSite Conformable Dressing (K981150), Unclassified Substantially Equivalent To: Th… | 2010 |
| * | K981150 | Solosite Gel Conformable DressingSummary page 1…Exempt, Product Code NAC PolyFIT+ Absorbing Dressings (K092351), Unclassified SoloSite Conformable Dressing (K981150), Unclassified Substantially Equivalent To: The Enluxtra' M Humifiber'M Wound Dressings are substantially equivalent in intended… | 1998 |
| * | — | Enluxtra Humifiber Wound Dressing Named without a submission number |
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 18 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K092351.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Enluxtra HumiflberT " Wound Dressings are intended as an effective barrier to reduce microbial penetration through the dressing. The Enluxtra Humifiber' M Wound Dressings are for use under healthcare professional's orders for the management of exuding wounds, partial and full thickness wounds, such as pressure ulcers (Stages Il-IY), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122297: Enluxtra Humifiber Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122297
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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