510(k) · Cleared
ClearedNivatopic Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nivagen Pharmaceuticals, Inc. · FRO Dressing, Wound, Drug
Cleared on Dec 20, 2013 as substantially equivalent to K110727 (Precision Dermatology Incorporated, 2011) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Dec 20, 2013
- Review
- 147 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K961758 (1996). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 6 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 5 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 4 generations backK060272 Locobase Wound and Skin EmulsionFerndale Laboratories, Inc. · 2007
- 3 generations backK083024 Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- 2 generations backK093051 Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
- 1 generation backK110727 Hylatopicplus CreamPrecision Dermatology Incorporated · 2011
- This deviceK132329 Nivatopic PlusNivagen Pharmaceuticals, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −6 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −5 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −4 | K060272 | Locobase Wound and Skin Emulsion | Ferndale Laboratories, Inc. | 2007 | — |
| −3 | K083024 | Hylatopic Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| −2 | K093051 | Hylatopic Plus Emollient Foam | Collegium Pharmaceutical Incorporated | 2009 | — |
| −1 | K110727 | Hylatopicplus Cream | Precision Dermatology Incorporated | 2011 | — |
| 0 (this device) | K132329 | Nivatopic Plus | Nivagen Pharmaceuticals, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K110727 | Hylatopicplus CreamSummary page 1…lent Devices: Nivatopic Plus is substantially equivalent to the currently marketed devices, Hylatopic Plus~M Cream, cleared under 510(K) # K110727, and distributed by PreCision Dermatology,… | 2011 |
| * | K113774 | HPR Plus Emollient FoamSummary page 2…tion NivatopicTM PlUS Inc. and HPRTM Plus Emollient Foam, cleared under 510(K) # K113774, and distributed by PruGen, IP Holdings Inc. The safety evaluation meets the requirements as set… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K110727.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Rx: NivatopicTM Plus is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. NivatopicTM Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132329: Nivatopic Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132329
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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