510(k) Report

510(k) · Cleared

Cleared

Vashe Wound Cleansing System

K060901510(k) TraditionalCleared Jun 29, 200687-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sterilox Technologies, Inc. · FRO Dressing, Wound, Drug

Cleared on Jun 29, 2006 as substantially equivalent to K965120 (Dpt Laboratories, Ltd., 1997) and 4 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1995.

Decided
Jun 29, 2006
Review
87 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K945802 (1995). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2004: 1 other ancestor1995: 1 other ancestor2001: 1 other ancestorK945802 · Dermagran Wound Cleanser with Zinc · Derma Sciences, Inc. · 1995K965120 · Allclenz Wound Cleanser · Dpt Laboratories, Ltd. · 1997K022670 · Carraklenz and Ultraklenz · Carrington Laboratories, Inc. · 2002K042729 · Dermacyn Wound Irrigation · Oculus Innovative Sciences, Inc. · 20051996199820002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor K042729 · Dermacyn Wound Irrigation · Oculus Innovative Sciences, Inc. · 2005K022670 · Carraklenz and Ultraklenz · Carrington Laboratories, Inc. · 2002K965120 · Allclenz Wound Cleanser · Dpt Laboratories, Ltd. · 1997K945802 · Dermagran Wound Cleanser with Zinc · Derma Sciences, Inc. · 19950
  1. Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
  2. 3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
  3. 2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
  4. 1 generation backK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
  5. This deviceK060901 Vashe Wound Cleansing SystemSterilox Technologies, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945802Dermagran Wound Cleanser with ZincDerma Sciences, Inc.1995—
−3K965120Allclenz Wound CleanserDpt Laboratories, Ltd.1997—
−2K022670Carraklenz and UltraklenzCarrington Laboratories, Inc.2002—
−1K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc.2005—
0 (this device)K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110
200410
200520
FIG. 1 — Lineage of K060901, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K965120Allclenz Wound Cleanser
Summary page 1
…me Wound Cleanser Classification Name Solution saline, (wound dressing) Predicate Device Allkle-nz Cleanser; Healthpoint Medical K965120, March 2 1 ~ 1997. CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670,…
Dpt Laboratories, Ltd.1997—
*K022670Carraklenz and Ultraklenz
Summary page 1
…ce Allkle-nz Cleanser; Healthpoint Medical K965120, March 2 1 ~ 1997. CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct. 17th, 2002. Deri/d/ynTh' Wound Cl. insei' Ocu,5ii i'nnov'ai~ve…
Carrington Laboratories, Inc.2002—
*K042729Dermacyn Wound Irrigation
Summary page 1
…ton Laboratories, Inc. K022670, Oct. 17th, 2002. Deri/d/ynTh' Wound Cl. insei' Ocu,5ii i'nnov'ai~ve Sciences, K042729, September 30th, 2004 and Dermacyn' M Wound Dressing, Oculus Innovative Sciences, K041161, February…
Oculus Innovative Sciences, Inc.2005—
*K041161Microcyn Wound Care Dressing
Summary page 1
…nov'ai~ve Sciences, K042729, September 30th, 2004 and Dermacyn' M Wound Dressing, Oculus Innovative Sciences, K041161, February Ist, 2005. l3iopure'M MTADTh Root Canal Cleanser, Dcntsply International,…
Oculus Innovative Sciences, Inc.20052
*K053167Biopure Mtad Root Canal Cleanser
Summary page 1
…ovative Sciences, K041161, February Ist, 2005. l3iopure'M MTADTh Root Canal Cleanser, Dcntsply International, K053167, December 8, 2005 Description The subject device is a wound cleansing solution that is intended for…
Dentsply Intl., Inc.2005—

Also cleared against K965120: 7 other devices →

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 11 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K965120.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Vashe TM Wound Cleanser is intended for cleansing, irrigating, moistening, debriding acute and chronic demreal lesions, such as Stage I-IV pressure and 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.

The Vashe TM Wound Cleanser is intended for use by qualified health care personnel trained in its use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K965120

7 other devices cite the same predicate.

  • K143444SynePure Wound CleanserSynedgen, Inc. · 2015
  • K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc. · 2009
  • K061467Exsept WC Wound CleanserAlcavis International, Inc. · 2007
  • K060113Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
  • K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
  • K040779Restore Wound CleanserHollister, Inc. · 2004

More from Sterilox Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K060901 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060901: Vashe Wound Cleansing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060901

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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