510(k) · Cleared
ClearedSpectricept Skin and Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Antimicrobials, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 21, 2025 as substantially equivalent to K213514 (Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc., 2023) after a 125-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Apr 21, 2025
- Review
- 125 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K914579 (1992). 62 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 13 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations between
- 3 generations backK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- 2 generations backK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- 1 generation backK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
- This deviceK243875 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 12 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 11 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 10 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 9 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 8 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 7 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 6 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 5 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 4 generations backK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- 3 generations backK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- 2 generations backK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- 1 generation backK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
- This deviceK243875 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −12 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −11 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −10 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −9 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −8 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −7 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −6 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −5 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| −4 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| −3 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| −2 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| −1 | K213514 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023 | — |
| 0 (this device) | K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | 2025 | — |
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 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K213514 | Spectricept Skin and Wound CleanserSummary page 5…c and Reconstructive Surgery Devices (DHT4B) 5. Legally Marketed Predicate Device(s) Device name: Spectricept Skin and Wound Cleanser 510(k) number: K213514 Manufacturer: Spectrum Antimicrobials, Inc, Petaluma, CA 94954… | 2023 |
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 33 years and passes through 11 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 62 ancestors have a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Spectricept Skin and Wound Cleanser for Professional Use: Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage 1-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin…
Read the full statement (111 words)
Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is
intended for cleansing, irrigating, moistening, debridement and removal of foreign material including
debris from wounds, and dermal lesions including stage 1-IV pressure ulcers, stasis ulcers, diabetic
ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the
skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening,
debridement and removal of foreign material including debris from of skin abrasions, lacerations,
minor irritations, cuts and intact skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243875: Spectricept Skin and Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243875
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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