510(k) · Cleared
ClearedLubrigyn cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uniderm Farmaceutici Srl · NUC Lubricant, Personal
Cleared on Feb 19, 2015 as substantially equivalent to K132772 (Uniderm Farmaceutici Srl, 2014) after a 28-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Feb 19, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 5 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 4 generations backK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
- 3 generations backK101241 Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)Lil Drug Store Products, Inc. · 2010
- 2 generations backK112217 ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R)…Polichem S.A · 2012
- 1 generation backK132772 Lubrigyn CreamUniderm Farmaceutici Srl · 2014
- This deviceK150147 Lubrigyn creamUniderm Farmaceutici Srl · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −5 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −4 | K062682 | CVS Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | 2007 | — |
| −3 | K101241 | Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator) | Lil Drug Store Products, Inc. | 2010 | — |
| −2 | K112217 | ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting… | Polichem S.A | 2012 | — |
| −1 | K132772 | Lubrigyn Cream | Uniderm Farmaceutici Srl | 2014 | — |
| 0 (this device) | K150147 | Lubrigyn cream | Uniderm Farmaceutici Srl | 2015 | — |
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 NUC? 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 NUC device
- #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K132772 | Lubrigyn CreamSummary page 4…Number code UNIDERM LUBRIGYN CREAM K132772 NUC FARMACEUTICI (single pocket-sized sachet) CONFIDENTIAL… | 2014 |
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 34 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NUC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUC
221in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUC
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUC
13in 2025
MAUDE reports naming product code NUC, 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 | 5 | 150 | 0 | 0 |
| 2008 | 7 | 271 | 1 | 6 |
| 2009 | 2 | — | 1 | 13 |
| 2010 | 4 | 124 | 0 | 2 |
| 2011 | 2 | — | 0 | 3 |
| 2012 | 6 | 269 | 0 | 6 |
| 2013 | 11 | 205 | 3 | 5 |
| 2014 | 11 | 264 | 0 | 14 |
| 2015 | 21 | 251 | 0 | 8 |
| 2016 | 14 | 181 | 0 | 14 |
| 2017 | 14 | 175 | 0 | 19 |
| 2018 | 15 | 114 | 0 | 6 |
| 2019 | 13 | 150 | 0 | 8 |
| 2020 | 19 | 180 | 0 | 2 |
| 2021 | 20 | 143 | 0 | 7 |
| 2022 | 14 | 112 | 0 | 7 |
| 2023 | 13 | 159 | 0 | 15 |
| 2024 | 6 | 178 | 0 | 13 |
| 2025 | 11 | 221 | 0 | 13 |
| 2026 | 12 | 104 | 0 | — |
What is it indicated for?
LUBRIGYN CREAM is a personal lubricant, for penile and/or vaginal application, intended to
moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and
supplement the body’s natural lubrication.
This product is not compatible with natural rubber latex, polyisoprene and polyurethane condoms
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150147 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150147: Lubrigyn cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150147
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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