510(k) · Cleared
ClearedHydrofera Bacteriostatic Wound 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 11, 2002 as substantially equivalent to K983276 (Hydrofera, LLC, 1999) after an 85-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Jan 11, 2002
- Review
- 85 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983276 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983276 Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 1999
- This deviceK013462 Hydrofera Bacteriostatic Wound DressingHydrofera, LLC · 2002
- Descendant · cites it directly · 2 of its ownK060832 Retro-Tech DressingRetro-Tech, LLC · 2007
- Descendant · cites it directly · 1 of its ownK130670 Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK190268 Hydrofera Blue READY - BorderHydrofera, LLC · 2019
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 |
|---|---|---|---|---|---|
| −1 | K983276 | Hydrofera Bacteristatic Nasal Dressing | Hydrofera, LLC | 1999 | — |
| 0 (this device) | K013462 | Hydrofera Bacteriostatic Wound Dressing | Hydrofera, LLC | 2002 | — |
| +1 | K060832 | Retro-Tech Dressing | Retro-Tech, LLC | 2007 | — |
| +1 | K130670 | Hydrofera Blue PU Bacteriostatic Dressing | Hydrofera, LLC | 2014 | — |
| +2 | K190268 | Hydrofera Blue READY - Border | Hydrofera, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K983276 | Hydrofera Bacteristatic Nasal Dressing Our OCR of the scanned summary read K983270, FDA’s number for Voyager Quad Cannula (Cardiothoracic Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Hydrofera Bacteriostatic Nasal Dressing”. | 1999 |
| * | — | Uttrafera wound dressing Named without a submission number |
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?
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, domor sites,-venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial bt post-surgical incisions, and other external wounds .inflicted by trauma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013462: Hydrofera Bacteriostatic Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013462
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026