510(k) · Cleared
ClearedRevera Wound Care, Model MDW0060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revalesio Corporation · FRO Dressing, Wound, Drug
Cleared on May 7, 2008 as substantially equivalent to K042729 (Oculus Innovative Sciences, Inc., 2005) and 1 other predicate after a 446-day review. Its family tree reaches back 4 generations to 1995. 1 of the 29 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- May 7, 2008
- Review
- 446 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945802 (1995). 6 ancestors in all. 22 later devices descend from it, 2 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 1 generation backK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
- This deviceK070463 Revera Wound Care, Model MDW0060Revalesio Corporation · 2008
- Descendant · cites it directly · 13 of its ownK083355 Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML…Blairex Laboratories, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- Descendant · 3 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Salinecites it directly · 2008
Most influential descendants
Showing 5 of 22 · See all- K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 2008 · cites it directly13descendants
- K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · 2 generations on8descendants
- K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · cites it directly7descendants
- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 3 generations on4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −3 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −2 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −1 | K042729 | Dermacyn Wound Irrigation | Oculus Innovative Sciences, Inc. | 2005 | — |
| 0 (this device) | K070463 | Revera Wound Care, Model MDW0060 | Revalesio Corporation | 2008 | — |
| +1 | K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | Blairex Laboratories, Inc. | 2008 | — |
| +2 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +1 | K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, Inc. | 2008 | Class I |
| +3 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +3 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K042729 | Dermacyn Wound IrrigationSummary page 1…te devices to which substantial equivalence is claimed: a) Oculus Innovative Sciences, Inc. "Dermacyn T M Wound Cleanser" FDA 51 0(k) No. K042729 Clearance to market this device given by FDA on May 17, 2005 FDA Device Classification: Class 1… | 2005 |
| * | K041161 | Microcyn Wound Care DressingSummary page 1…ion Number: 21CFR 880.5090 FDA Product Code: KMF b) Oculus Innovative Sciences, Inc. "Dermacyn TM Wound Dressing" FDA 51 0(k) No. K041161 Clearance to market this device given by FDA on May 3, 2005 FDA Device Classification: Unclassified… | 2005 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K083355 (Blairex Laboratories, Inc., 2008) has gone furthest, with 13 descendants of its own.
- 10 other devices also cite its predicate K042729.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
REVERATM Wound Care is indicated for moisiening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin, in addition to moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor bums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070463: Revera Wound Care, Model MDW0060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070463
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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