510(k) · Cleared
ClearedAtteris Antimicrobial Skin & Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochal Industries, LLC · FRO Dressing, Wound, Drug
Cleared on Jul 28, 2016 as substantially equivalent to K073547 (Anacapa Technologies, Inc., 2008) after a 183-day review. Its family tree reaches back 6 generations to 1992. 9 later devices descend from it.
- Decided
- Jul 28, 2016
- Review
- 183 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914579 (1992). 26 ancestors in all, the oldest K890354 (1989). 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 2 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 1 generation backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- This deviceK160192 Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC · 2016
- Descendant · cites it directly · 6 of its ownK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
- Descendant · 2 generations on · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- Descendant · 3 generations on · 2 of its ownK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- Descendant · 4 generations on · 0 of its ownK253996 BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
- Descendant · 4 generations on · 0 of its ownK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021 · cites it directly6descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 2 generations on3descendants
- K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022 · 3 generations on2descendants
- K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026 · 4 generations on0descendants
- K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −1 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| 0 (this device) | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | Rochal Industries, LLC | 2016 | — |
| +1 | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
| +2 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +3 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
| +4 | K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026 | — |
| +4 | K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 6…Skin & Wound and Wound Cleanser Wound Cleanser Cleanser (K073547) (K141660) Biocompatibility Biocompatible Biocompatible Biocom… | 2008 |
| † | K141660 | Nawalution Skin and Wound Cleanser | 2014 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K210536 (Irrimax Corporation, 2021) has gone furthest, with 6 descendants of its own.
- 16 other devices also cite its predicate K073547.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Rx Only: Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
OTC use: Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160192: Atteris Antimicrobial Skin & Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160192
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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