510(k) · Cleared
ClearedHydrofera Blue PU Bacteriostatic Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrofera, LLC · FRO Dressing, Wound, Drug
Cleared on Jan 2, 2014 as substantially equivalent to K013462 (Hydrofera, LLC, 2002) and 1 other predicate after a 296-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Jan 2, 2014
- Review
- 296 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K946245 (1995). 10 ancestors in all, the oldest K871166 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK946245 Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
- 4 generations backK983173 Biatain Foam Adhesive DressingColoplast Corp. · 1998
- 3 generations backK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
- 2 generations backK032742 Silver Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2004
- 1 generation backK060832 Retro-Tech DressingRetro-Tech, LLC · 2007
- This deviceK130670 Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 2014
- Descendant · cites it directly · 0 of its ownK190268 Hydrofera Blue READY - BorderHydrofera, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K190268Hydrofera Blue READY - BorderHydrofera, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | 1995 | — |
| −4 | K983173 | Biatain Foam Adhesive Dressing | Coloplast Corp. | 1998 | — |
| −3 | K022416 | Contreet Foam Adhesive/Non-Adhesive | Coloplast Corp. | 2003 | — |
| −2 | K032742 | Silver Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| −1 | K060832 | Retro-Tech Dressing | Retro-Tech, LLC | 2007 | — |
| 0 (this device) | K130670 | Hydrofera Blue PU Bacteriostatic Dressing | Hydrofera, LLC | 2014 | — |
| +1 | K190268 | Hydrofera Blue READY - Border | Hydrofera, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013462 | Hydrofera Bacteriostatic Wound DressingSummary page 2…* Where used * Anatomical sites Cornparison Table ______________________ Hydrofera Blue PU Hydrofera K# 013462 Retro Tech K#060832 dressing______________ Local Management of Local management of… | 2002 |
| * | K060832 | Retro-Tech DressingSummary page 1…to which we are claiming equivalence (807.92(a) (3): K#Applicant Device Name 1(01462 droeraLLCHydrofera Blue K(060832 Retro-Tech, LLC RTD Dressing Description of the Device: Hydrofera Blue PU Antibacterial Dressing is a steri… | 2007 |
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 |
|---|---|---|---|
| K190268 | Hydrofera Blue READY - Border | 2019 | 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 19 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K190268 (Hydrofera, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013462.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Hydrafera Blue PU Antibacterial Wound Dressings are intended as exteral dressings for use In local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130670: Hydrofera Blue PU Bacteriostatic Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130670
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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