510(k) · Cleared
Clearedpjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
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 Jan 21, 2021 as substantially equivalent to K200114 (Biofilm, Inc., 2020) after a 307-day review. Its family tree reaches back 5 generations to 1981. 2 later devices descend from it.
- Decided
- Jan 21, 2021
- Review
- 307 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810310 (1981). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- 2 generations backK141581 Astroglide NaturalBiofilm, Inc. · 2014
- 1 generation backK200114 Astroglide Organix LiquidBiofilm, Inc. · 2020
- This deviceK200731 pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur…Pjur Group Luxembourg S.A. · 2021
- Descendant · cites it directly · 1 of its ownK240081 Human LubricantJiangxi Wulinxiang Biological Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK251773 Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor…Shenzhen Yongquan Medical Devices Co., Ltd. · 2025
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 |
|---|---|---|---|---|---|
| −5 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −4 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −3 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| −2 | K141581 | Astroglide Natural | Biofilm, Inc. | 2014 | — |
| −1 | K200114 | Astroglide Organix Liquid | Biofilm, Inc. | 2020 | — |
| 0 (this device) | K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR… | Pjur Group Luxembourg S.A. | 2021 | — |
| +1 | K240081 | Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. | 2024 | — |
| +2 | K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin… | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K200114 | Astroglide Organix Liquid Cleared while this submission was under review Summary page 4…Product Code: NUC (Lubricant, Personal) Class: II PREDICATE DEVICE: Astroglide® Organix® Liquid, K200114 The predicate device has not been subject to a design-… | 2020 |
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 |
|---|---|---|---|
| K240081 | Human Lubricant | 2024 | 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 40 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K240081 (Jiangxi Wulinxiang Biological Technology Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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® AQUA Baseline 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. pjur® AQUA Guarana for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual…
Read the full statement (172 words)
pjur® AQUA Baseline 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® AQUA Guarana 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® BACK DOOR anal Provitamin B5 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® AQUA ProVitamin B5 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200731 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200731: pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200731
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