510(k) · Cleared
Clearedpjur NATURE Touch, 100 ml
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pjur Group Luxembourg S.A. · NUC Lubricant, Personal
Cleared on May 21, 2026 as substantially equivalent to K182027 (Trigg Laboratories Dba Wet International, 2018) after a 132-day review. Its family tree reaches back 5 generations to 1981.
- Decided
- May 21, 2026
- Review
- 132 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810310 (1981). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK061466 IntimolDlc Laboratories, Inc. · 2006
- 2 generations backK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
- 1 generation backK182027 Wet Organics Personal LubricantTrigg Laboratories Dba Wet International · 2018
- This deviceK260068 pjur NATURE Touch, 100 mlPjur Group Luxembourg S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −4 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −3 | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| −2 | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | Seven Oaks Ranch, Inc. | 2013 | — |
| −1 | K182027 | Wet Organics Personal Lubricant | Trigg Laboratories Dba Wet International | 2018 | — |
| 0 (this device) | K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 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 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 |
|---|---|---|---|
| * | K182027 | Wet Organics Personal LubricantSummary page 5…t Code: NUC (lubricant, personal) Device Class: II 3. Predicate Device Information: Predicate 510(k) Number K182027 Predicate Trade Name Wet Organics Personal Lubricant Predicate Manufacturer Trigg Laboratories DBAWet… | 2018 |
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 45 years and passes through 6 companies; a new generation was cleared every 7.5 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K182027.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
pjur® NATURE Touch, 100 ml is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260068: pjur NATURE Touch, 100 ml.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260068
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026