510(k) · Cleared
ClearedHydrofera Blue READY - Border
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 Nov 6, 2019 as substantially equivalent to K130670 (Hydrofera, LLC, 2014) after a 271-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 6, 2019
- Review
- 271 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K946245 (1995). 11 ancestors in all, the oldest K871166 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK946245 Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
- 5 generations backK983173 Biatain Foam Adhesive DressingColoplast Corp. · 1998
- 4 generations backK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
- 3 generations backK032742 Silver Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2004
- 2 generations backK060832 Retro-Tech DressingRetro-Tech, LLC · 2007
- 1 generation backK130670 Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 2014
- This deviceK190268 Hydrofera Blue READY - BorderHydrofera, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | 1995 | — |
| −5 | K983173 | Biatain Foam Adhesive Dressing | Coloplast Corp. | 1998 | — |
| −4 | K022416 | Contreet Foam Adhesive/Non-Adhesive | Coloplast Corp. | 2003 | — |
| −3 | K032742 | Silver Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| −2 | K060832 | Retro-Tech Dressing | Retro-Tech, LLC | 2007 | — |
| −1 | K130670 | Hydrofera Blue PU Bacteriostatic Dressing | Hydrofera, LLC | 2014 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K130670 | Hydrofera Blue PU Bacteriostatic DressingSummary page 4…nel: General & Plastic Surgery 3. Predicate Device(s) Predicate Device Name: Hydrofera Blue PU Antibacterial Dressing (K130670) Hydrofera, LLC November 6, 2019 CONFIDENTIAL Additional Information – K190268… | 2014 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190268: Hydrofera Blue READY - Border.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190268
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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