510(k) · Cleared
ClearedBioderm Sciences Wound Dressing
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 4, 2004 as substantially equivalent to K993969 (Winchester Laboratories, LLC, 1999) and 3 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1994. 1 of the 35 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Jun 4, 2004
- Review
- 80 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K935060 (1994). 5 ancestors in all. 29 later devices descend from it, 4 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK935060 Brennen Medical Sterile Saline SolutionBrennen Medical, Inc. · 1994
- 1 generation backK972185 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd. · 1998
- This deviceK040683 Bioderm Sciences Wound DressingBioderm Sciences, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK063063 Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007
- 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)
Showing 5 of 29 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 29 · See all- K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007 · cites it directly14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935060 | Brennen Medical Sterile Saline Solution | Brennen Medical, Inc. | 1994 | — |
| −1 | K972185 | 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride | Steripak, Ltd. | 1998 | — |
| 0 (this device) | K040683 | Bioderm Sciences Wound Dressing | Bioderm Sciences, Inc. | 2004 | — |
| +1 | K063063 | Silvacide Skin & Wound Moisturizing Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 2 | 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 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? (4)
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 |
|---|---|---|---|
| * | K993969 | Saljet Single Dose Sterile Saline Topical SolutionSummary page 1…ound Solution Clas~sification Name: Liquid Bandage Predicate Devices: K993969 Saijet Single Dose Sterile Saline Topical Solution K972 185 20 ml Normal Saline Topical Solu… | 1999 |
| * | K972185 | 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSummary page 1…K993969 Saijet Single Dose Sterile Saline Topical Solution K972 185 20 ml Normal Saline Topical Solution, 0,9% w/v Sodium Chloonde… | 1998 |
| * | K941999 | Hypertonic Saline Wet Dressing - SterileSummary page 1…K972 185 20 ml Normal Saline Topical Solution, 0,9% w/v Sodium Chloonde K94 1999 Hypertonic saline wet dressing - sterile K945802 Derrnagran wound cleanser with zi… | 1994 |
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 1…K94 1999 Hypertonic saline wet dressing - sterile K945802 Derrnagran wound cleanser with zinc Description: external wound… | 1995 |
What descends from it? (29)
See all 294 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 10 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063063 (Medical Molecular Therapuetics, LLC, 2007) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K993969.
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 Solution is intended to cleanse, irrigate and externally manage dernal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and full-thickness wounds, bums and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
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/K040683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040683: Bioderm Sciences Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040683
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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