510(k) · Cleared
ClearedHychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aquilabs Us, LLC · FRO Dressing, Wound, Drug
Cleared on Apr 13, 2018 as substantially equivalent to K133542 (Innovacyn, Inc., 2014) and 3 other predicates after a 70-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Apr 13, 2018
- Review
- 70 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K914579 (1992). 48 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations between
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 1 generation backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- This deviceK180305 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin…Aquilabs Us, LLC · 2018
Show all 10 generations
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 8 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 7 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 6 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 5 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 4 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 1 generation backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- This deviceK180305 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin…Aquilabs Us, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −9 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −8 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −7 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −6 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −5 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −2 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −1 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| 0 (this device) | K180305 | Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) | Aquilabs Us, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K133542 | Puracyn Plus Skin and WoundSummary page 5…General and Plastic Surgery Identification of Legally Marketed Device for Substantial Equivalence Comparison (21 CFR 807.92(a)(3)) Primary Predicate Device: K133542, Puracyn Plus™, Skin and Wound Care by Innovacyn, Inc. Secondary Predicate Device: K123072… | 2014 |
| * | K123072 | Vashe Wound Therapy SolutionSummary page 5…(3)) Primary Predicate Device: K133542, Puracyn Plus™, Skin and Wound Care by Innovacyn, Inc. Secondary Predicate Device: K123072, Vashe® Wound Therapy Solution. K113693, Nixal ® Wound and Skin Care.… | 2013 |
| * | K113693 | Nixall TM Wound and Skin CareSummary page 5…K133542, Puracyn Plus™, Skin and Wound Care by Innovacyn, Inc. Secondary Predicate Device: K123072, Vashe® Wound Therapy Solution. K113693, Nixal ® Wound and Skin Care. K113820, Neutrophase® Skin and Wo… | 2012 |
| * | K113820 | Neutrophase Antimicrobial Wound CleanserSummary page 5…ry Predicate Device: K123072, Vashe® Wound Therapy Solution. K113693, Nixal ® Wound and Skin Care. K113820, Neutrophase® Skin and Wound Cleanser. Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are similar… | 2012 |
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 26 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 48 ancestors have a recall of any class.
- 3 other devices also cite its predicate K133542.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor cuts, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings. Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor cuts, minor abrasions, minor lacerations, cleansing…
Read the full statement (106 words)
OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor cuts, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings.
Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor cuts, minor abrasions, minor lacerations, cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, leg ulcers, 1st and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180305: Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180305
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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