510(k) · Cleared
ClearedModification to Zenieva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gorbec Pharmaceutical Services, Inc. · NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Cleared on Oct 23, 2008 as substantially equivalent to K073246 (Gorbec Pharmaceutical Services, Inc., 2008) after a 24-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Oct 23, 2008
- Review
- 24 days
- Class
- Class I
- Product code
- NAE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961758 (1996). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 3 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 2 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 1 generation backK073246 ZenievaGorbec Pharmaceutical Services, Inc. · 2008
- This deviceK082865 Modification to ZenievaGorbec Pharmaceutical Services, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK083721 Modification to ZenievaRiver'S Edge Pharmaceuticals, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK100839 BarirepGorbec Pharmaceutical Services, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −3 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −2 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −1 | K073246 | Zenieva | Gorbec Pharmaceutical Services, Inc. | 2008 | — |
| 0 (this device) | K082865 | Modification to Zenieva | Gorbec Pharmaceutical Services, Inc. | 2008 | — |
| +1 | K083721 | Modification to Zenieva | River'S Edge Pharmaceuticals, LLC | 2009 | — |
| +2 | K100839 | Barirep | Gorbec Pharmaceutical Services, Inc. | 2010 | — |
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 | 1 | 0 |
| 2010 | 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 NAE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K073246 | ZenievaSummary page 1…ec Pharmaceutical Services Inc. believes the modification submitted for Zenieva is substantially equivalent to the currently approved device, cleared under K073246. Device Description and Design Zenieva is a non-sterile, semi-viscous emulsion intended for topical application.… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083721 | Modification to Zenieva | 2009 | 1 |
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 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K083721 (River'S Edge Pharmaceuticals, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K073246.
How does its category compare?
All NAE devicesNAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NAE
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NAE
Too few NAE 510(k)s in any year since 2007 to give a median.
Recalls per year · NAE
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAE
7in 2025
MAUDE reports naming product code NAE, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis.
Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082865: Modification to Zenieva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082865
Report an extraction error
Are you the manufacturer?
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