510(k) · Cleared
ClearedHARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxigen Biotech, Inc. · NUC Lubricant, Personal
Cleared on Sep 3, 2026 as substantially equivalent to K141034 (Church & Dwight Co., Inc., 2014) after a 265-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Sep 3, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). 11 ancestors in all. 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 backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 3 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 2 generations backK122054 Lifestyles Natural Personal LubricantAnsell Healthcare Products, LLC · 2013
- 1 generation backK141034 Azul Personal LubricantChurch & Dwight Co., Inc. · 2014
- This deviceK253989 HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm…Maxigen Biotech, Inc. · 2026
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 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −3 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| −2 | K122054 | Lifestyles Natural Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| −1 | K141034 | Azul Personal Lubricant | Church & Dwight Co., Inc. | 2014 | — |
| 0 (this device) | K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water… | Maxigen Biotech, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K141034 | Azul Personal LubricantSummary page 5…Regulation Name：Condom Product Code：NUC (lubricant, personal) Class：Class II 3. PREDICATE DEVICE Predicate device：Azul Personal Lubricant (K141034) The predicate device has not been subject to a design-related recall. 4. DEVICE DESCRIPTION HARU Orgasm by jack h… | 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 45 years and passes through 6 companies; a new generation was cleared every 9.9 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K141034.
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?
HARU Orgasm by jack herer water based lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. HARU Orgasm water based lubricant is a personal lubricant for…
Read the full statement (165 words)
HARU Orgasm by jack herer water based lubricant is a personal lubricant for penile and/or vaginal application, intended
to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural
lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with
polyisoprene and polyurethane condoms.
HARU Orgasm water based lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate
and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and
polyurethane condoms.
HARU STEAMY water based lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate
and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is compatible with natural rubber latex condoms. This product is not compatible with 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/K253989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253989: HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253989
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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