510(k) · Cleared
ClearedRestore Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KMF Bandage, Liquid
Cleared on May 17, 2004 as substantially equivalent to K022670 (Carrington Laboratories, Inc., 2002) and 2 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1995. 1 of the 33 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it.
- Decided
- May 17, 2004
- Review
- 52 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945802 (1995). 4 ancestors in all. 28 later devices descend from it, 2 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 2 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 1 generation backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- This deviceK040779 Restore Wound CleanserHollister, Inc. · 2004
- 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 · cites it directly · 13 of its ownK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · 2 generations on · 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
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Saline2 generations on · 2008
Most influential descendants
Showing 5 of 28 · See all- K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 2008 · cites it directly13descendants
- K042084Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005 · 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 · 2 generations on7descendants
- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −2 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −1 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| 0 (this device) | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| +1 | K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | Blairex Laboratories, Inc. | 2008 | — |
| +1 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| +2 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +2 | K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, Inc. | 2008 | Class I |
| +3 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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.
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 KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K022670 | Carraklenz and UltraklenzSummary page 4…pared - March 23, 2004 2. Name of Device: Restore Wound Cleanser 3. Name of Predicate Device(s) • Carrington Carra Klenz Wound Cleanser K022670 * Allclenz Wound Cleanser K965 120 * Dermia Sciences Dermagran Wound Cleanser with Zinc K945 802 4. D… | 2002 |
| * | K965120 | Allclenz Wound CleanserSummary page 4…e: Restore Wound Cleanser 3. Name of Predicate Device(s) • Carrington Carra Klenz Wound Cleanser K022670 * Allclenz Wound Cleanser K965 120 * Dermia Sciences Dermagran Wound Cleanser with Zinc K945 802 4. Description of Device The Restore… | 1997 |
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 4…• Carrington Carra Klenz Wound Cleanser K022670 * Allclenz Wound Cleanser K965 120 * Dermia Sciences Dermagran Wound Cleanser with Zinc K945 802 4. Description of Device The Restore Wound Cleanser is a buffered isotonic water based surfactant solution th… | 1995 |
What descends from it? (28)
See all 282 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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083355 (Blairex Laboratories, Inc., 2008) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K022670.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, 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 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040779 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040779: Restore Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040779
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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