510(k) · Cleared
ClearedBioderm Sciences Wound Healing Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioderm Sciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 15, 2005 as substantially equivalent to K040683 (Bioderm Sciences, Inc., 2004) and 2 other predicates after a 316-day review. Its family tree reaches back 4 generations to 1995. 1 of the 24 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Jun 15, 2005
- Review
- 316 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945802 (1995). 10 ancestors in all, the oldest K935060 (1994). 13 later devices descend from it, 3 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 1 generation backK040779 Restore Wound CleanserHollister, Inc. · 2004
- This deviceK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK161311 USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9%…Strukmyer Medical, LLC · 2016
- Descendant · cites it directly · 2 of its ownK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
- Descendant · 2 generations on · 1 of its ownK173276 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK172486 Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline…Anexa Biomedical, Inc. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Salinecites it directly · 2008
Most influential descendants
Showing 5 of 13 · See all- K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · cites it directly7descendants
- K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC · 2016 · 2 generations on2descendants
- K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014 · cites it directly2descendants
- K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · 2 generations on1descendant
- K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −3 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −2 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −1 | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| 0 (this device) | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| +1 | K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, Inc. | 2008 | Class I |
| +2 | K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium… | Strukmyer Medical, LLC | 2016 | — |
| +1 | K141660 | Nawalution Skin and Wound Cleanser | Nawa Heilmittel GmbH | 2014 | — |
| +2 | K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | Medline Industries, Inc. | 2018 | 1 |
| +2 | K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9%… | Anexa Biomedical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 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? (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 |
|---|---|---|---|
| * | K040683 | Bioderm Sciences Wound DressingSummary page 1…oDerm Wound Spray Classification Name: Liquid Bandage Predicate Devices: BioDerm Wound Solution K040683 Dermagran wound cleanser with zinc K945802 Restore Wound Cleanser… | 2004 |
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 1…erm Wound Solution K040683 Dermagran wound cleanser with zinc K945802 Restore Wound Cleanser K040779 Description: BioDerm Wound Spray is… | 1995 |
| * | K040779 | Restore Wound CleanserSummary page 1…agran wound cleanser with zinc K945802 Restore Wound Cleanser K040779 Description: BioDerm Wound Spray is an acidic zinc-saline wet dressing for external wound management. It aids the body in the h… | 2004 |
What descends from it? (13)
See all 133 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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K083042 (Nurse Assist, Inc., 2008) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K040683.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
BioDerm Sciences Wound Spray is intended to cleanse, rinse and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, bums and ulcers (diabetic, venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
BioDern Sciences Wound Spray is intendedlo clean, rinse and externally manage skin wounds such as minor lacerations, minor cuts, minor bums and abrasions.
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/K042084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042084: Bioderm Sciences Wound Healing Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042084
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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