510(k) · Cleared
ClearedPjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME!
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 Apr 6, 2015 as substantially equivalent to K130012 (Trigg Laboratories, Inc., 2013) after a 265-day review. Its family tree reaches back 3 generations to 2006. 2 later devices descend from it.
- Decided
- Apr 6, 2015
- Review
- 265 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062796 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK062796 K-Y Brand IntriguePersonal Products Co. · 2006
- 2 generations backK110690 One Personal Lubricant (Silicone)One · 2012
- 1 generation backK130012 Wet Platinum Personal LubricantTrigg Laboratories, Inc. · 2013
- This deviceK141913 Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse…Pjur Group Luxembourg S.A. · 2015
- Descendant · cites it directly · 0 of its ownK210242 Astroglide X Silicone Personal LubricantBiofilm, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK171516 Flip LubeImquest Biosciences, Inc. · 2018
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 |
|---|---|---|---|---|---|
| −3 | K062796 | K-Y Brand Intrigue | Personal Products Co. | 2006 | — |
| −2 | K110690 | One Personal Lubricant (Silicone) | One | 2012 | — |
| −1 | K130012 | Wet Platinum Personal Lubricant | Trigg Laboratories, Inc. | 2013 | — |
| 0 (this device) | K141913 | Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME! | Pjur Group Luxembourg S.A. | 2015 | — |
| +1 | K210242 | Astroglide X Silicone Personal Lubricant | Biofilm, Inc. | 2021 | — |
| +1 | K171516 | Flip Lube | Imquest Biosciences, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K130012 | Wet Platinum Personal LubricantSummary page 4…cant Classification Name Condom (21 CFR §884.5300, Product Code NUC) Class Class II Predicate Devices Wet Platinum Premium Lubricant®, K130012 Description The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non- sterile, silicon… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K210242 (Biofilm, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K130012.
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?
pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and 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/K141913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141913: Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME!.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141913
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