510(k) · Cleared
ClearedRetro-Tech Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retro-Tech, LLC · FRO Dressing, Wound, Drug
Cleared on Mar 13, 2007 as substantially equivalent to K013462 (Hydrofera, LLC, 2002) and 2 other predicates after a 351-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 13, 2007
- Review
- 351 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K946245 (1995). 9 ancestors in all, the oldest K871166 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK946245 Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
- 3 generations backK983173 Biatain Foam Adhesive DressingColoplast Corp. · 1998
- 2 generations backK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
- 1 generation backK032742 Silver Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2004
- This deviceK060832 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | 1995 | — |
| −3 | K983173 | Biatain Foam Adhesive Dressing | Coloplast Corp. | 1998 | — |
| −2 | K022416 | Contreet Foam Adhesive/Non-Adhesive | Coloplast Corp. | 2003 | — |
| −1 | K032742 | Silver Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| 0 (this device) | 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 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K013462 | Hydrofera Bacteriostatic Wound DressingSummary page 1…Wound Dressing The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: K# ____Applicant Device Name K013462 Hydrofera, LLC Hydrofera Blue K022416 Coloplast Corp. Contree… | 2002 |
| * | K022416 | Contreet Foam Adhesive/Non-AdhesiveSummary page 1…ivalence [807.92(a)(3)]: K# ____Applicant Device Name K013462 Hydrofera, LLC Hydrofera Blue K022416 Coloplast Corp. Contreet Foam Adhesive/Non- _____ _ ___ ____ ___ ___… | 2003 |
| * | K032742 | Silver Foam Wound DressingSummary page 1…Hydrofera Blue K022416 Coloplast Corp. Contreet Foam Adhesive/Non- _____ _ ___ ____ ___ ___ ___ adhesive K032742 Advanced Medical Silver Foam Wound Dressing _____ ____ Solutions, Inc.… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130670 | Hydrofera Blue PU Bacteriostatic Dressing | 2014 | 1 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K130670 (Hydrofera, LLC, 2014) has gone furthest, with 1 descendant 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. 2007, 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?
Retro-Tech Dressing is indicated for moderately to heavily exuding,
partial to full thickness wounds, including:
* Pressure ulcers
* Leg ulcers
Diabetic foot ulcers
* Graft wounds and donor sites
* Skin tears
* First and second degree burns
* Surgical wounds
Lacerations and abrasions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060832: Retro-Tech Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060832
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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