510(k) · Cleared
ClearedPjur Original, Pjur Woman, Pjur Man Extreme Glide
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 Jul 18, 2014 as substantially equivalent to K040428 (R & K International Cosmetics, 2005) after a 270-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Jul 18, 2014
- Review
- 270 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040428 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040428 Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone…R & K International Cosmetics · 2005
- This deviceK133233 Pjur Original, Pjur Woman, Pjur Man Extreme GlidePjur Group Luxembourg S.A. · 2014
- Descendant · cites it directly · 1 of its ownK150153 Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based…Package Solutions, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK213892 Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC · 2023
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 |
|---|---|---|---|---|---|
| −1 | K040428 | Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex… | R & K International Cosmetics | 2005 | — |
| 0 (this device) | K133233 | Pjur Original, Pjur Woman, Pjur Man Extreme Glide | Pjur Group Luxembourg S.A. | 2014 | — |
| +1 | K150153 | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based… | Package Solutions, LLC | 2015 | — |
| +2 | K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | Rb Health (Us), LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K040428 | Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone…Summary page 1…__ _ __ _ _ _ _ 21i CFR § 8 84 .5 3 00 , Pro du ct C o de N _ _ _ _ Predicate Devices Erozone Glide, K040428 lubricants are non-sterile, silicone-based personal lubricants. These… | 2005 |
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 |
|---|---|---|---|
| K150153 | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss… | 2015 | 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?
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133233: Pjur Original, Pjur Woman, Pjur Man Extreme Glide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133233
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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