510(k) · Cleared
ClearedNeosalus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinnova Pharmaceuticals · FRO Dressing, Wound, Drug
Cleared on Sep 12, 2008 as substantially equivalent to K041342 (Stiefel Laboratories, Inc., 2005) and 1 other predicate after a 589-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 589 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961758 (1996). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 2 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 1 generation backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- This deviceK070309 NeosalusQuinnova Pharmaceuticals · 2008
- Descendant · cites it directly · 4 of its ownK090585 Neosalus CreamQuinnova Pharmaceuticals · 2009
- Descendant · 2 generations on · 0 of its ownK240722 Derma-R Cream (Derma-R Cream)Raya Pharmaceuticals, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK170911 NEOCERA Advanced Barrier CreamExeltis USA Dermatology, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK113807 Dexeryl CreamPierre Fabre Medical Devices · 2012
- Descendant · 2 generations on · 0 of its ownK091719 Neosalus LotionQuinnova Pharmaceuticals · 2009
Most influential descendants
Showing 5 of 5 · See all- K090585Neosalus CreamQuinnova Pharmaceuticals · 2009 · cites it directly4descendants
- K240722Derma-R Cream (Derma-R Cream)Raya Pharmaceuticals, LLC · 2024 · 2 generations on0descendants
- K170911NEOCERA Advanced Barrier CreamExeltis USA Dermatology, LLC · 2017 · 2 generations on0descendants
- K113807Dexeryl CreamPierre Fabre Medical Devices · 2012 · 2 generations on0descendants
- K091719Neosalus LotionQuinnova Pharmaceuticals · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −2 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −1 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| 0 (this device) | K070309 | Neosalus | Quinnova Pharmaceuticals | 2008 | — |
| +1 | K090585 | Neosalus Cream | Quinnova Pharmaceuticals | 2009 | — |
| +2 | K240722 | Derma-R Cream (Derma-R Cream) | Raya Pharmaceuticals, LLC | 2024 | — |
| +2 | K170911 | NEOCERA Advanced Barrier Cream | Exeltis USA Dermatology, LLC | 2017 | — |
| +2 | K113807 | Dexeryl Cream | Pierre Fabre Medical Devices | 2012 | — |
| +2 | K091719 | Neosalus Lotion | Quinnova Pharmaceuticals | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K041342 | Impruv a.I. Cream Wound and Skin EmulsionSummary page 1…Name: Neosalus Device Common/Classification Name: Dressing. Wound and Burn. Hydrogel with Drug and/or Biologic Predicate Devices Name and 510(k) Numbers: Mimyx Cream (K041342) and Biafine Wound Dressing Emulsion (K964240) Device 'Description: Neosalus is fragrance-free, water-soluble foam dressing form… | 2005 |
| * | K964240 | Biafine Wound Dressing EmulsionSummary page 1…Name: Dressing. Wound and Burn. Hydrogel with Drug and/or Biologic Predicate Devices Name and 510(k) Numbers: Mimyx Cream (K041342) and Biafine Wound Dressing Emulsion (K964240) Device 'Description: Neosalus is fragrance-free, water-soluble foam dressing formulated for the management and relief of irrita… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090585 | Neosalus Cream | 2009 | 4 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K090585 (Quinnova Pharmaceuticals, 2009) has gone furthest, with 4 descendants of its own.
- 16 other devices also cite its predicate K041342.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Neosalus is indicated for management and relief of irritation associated with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070309: Neosalus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070309
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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