510(k) · Cleared
ClearedBioderm Sciences Wound Cream
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 Oct 17, 2005 as substantially equivalent to K040683 (Bioderm Sciences, Inc., 2004) and 2 other predicates after a 413-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Oct 17, 2005
- Review
- 413 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945802 (1995). 15 ancestors in all, the oldest K935060 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 4 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 3 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 2 generations backK040779 Restore Wound CleanserHollister, Inc. · 2004
- 1 generation backK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- This deviceK042352 Bioderm Sciences Wound CreamBioderm Sciences, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK063805 Silcryst Silver Antimicrobial Wound Cream, Model a-00901Nucryst Pharmaceuticals, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063805Silcryst Silver Antimicrobial Wound Cream, Model a-00901Nucryst Pharmaceuticals, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −4 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −3 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −2 | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| −1 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| 0 (this device) | K042352 | Bioderm Sciences Wound Cream | Bioderm Sciences, Inc. | 2005 | — |
| +1 | K063805 | Silcryst Silver Antimicrobial Wound Cream, Model a-00901 | Nucryst Pharmaceuticals, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
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? (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…r Device Name: BioDenn Sciences Wound Cream Classification Name: Wound Dressing Predicate Device; BioDerm Sciences Wound Solution K040683 BioDerm Sciences Wound Spray K042084 Dermagran Wound Management System K970660 Descri… | 2004 |
| * | K042084 | Bioderm Sciences Wound Healing Spray Cleared while this submission was under review Summary page 1…ation Name: Wound Dressing Predicate Device; BioDerm Sciences Wound Solution K040683 BioDerm Sciences Wound Spray K042084 Dermagran Wound Management System K970660 Description: BioDerm Sciences Wound cream is an aqu… | 2005 |
| * | K970660 | Dermagran Wound Management SystemSummary page 1…rm Sciences Wound Solution K040683 BioDerm Sciences Wound Spray K042084 Dermagran Wound Management System K970660 Description: BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream fbr external wound… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063805 | Silcryst Silver Antimicrobial Wound Cream, Model a-00901 | 2007 | 0 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K063805 (Nucryst Pharmaceuticals, Inc., 2007) has gone furthest, with 0 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 Cream is intended to externally manage derral lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, I " and 2a degree 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042352: Bioderm Sciences Wound Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042352
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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