510(k) · Cleared
ClearedJO H20 Water Based Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Consortium, Inc. · NUC Lubricant, Personal
Cleared on Jul 8, 2015 as substantially equivalent to K051295 (Westridge Laboratories, Inc., 2006) after a 134-day review. Its family tree reaches back 4 generations to 1990. 12 later devices descend from it.
- Decided
- Jul 8, 2015
- Review
- 134 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903910 (1990). 8 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 3 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 2 generations backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- 1 generation backK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- This deviceK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- Descendant · 2 generations on · 6 of its ownK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
- Descendant · 3 generations on · 5 of its ownK200208 Agape Warming Personal LubricantCC Wellness, LLC · 2020
- Descendant · cites it directly · 1 of its ownK203654 Solevy Co. LLC Water-Based Personal LubricantSolevy Co., LLC · 2021
- Descendant · 4 generations on · 1 of its ownK203257 LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016 · cites it directly9descendants
- K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…United Consortium · 2019 · 2 generations on6descendants
- K200208Agape Warming Personal LubricantCC Wellness, LLC · 2020 · 3 generations on5descendants
- K203654Solevy Co. LLC Water-Based Personal LubricantSolevy Co., LLC · 2021 · cites it directly1descendant
- K203257LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −3 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −2 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| −1 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| 0 (this device) | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| +1 | K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | 2016 | — |
| +2 | K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant… | United Consortium | 2019 | — |
| +3 | K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | 2020 | — |
| +1 | K203654 | Solevy Co. LLC Water-Based Personal Lubricant | Solevy Co., LLC | 2021 | — |
| +4 | K203257 | LUBi Water Based Personal Lubricant | Boya Biotechnology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K051295 | I-D GlideSummary page 4…Product Name: I-‐D Glide Personal Lubricant 510(k) Number: K051295 Manufacturer: Westridge Laboratories, Inc.… | 2006 |
What descends from it? (12)
See all 122 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 25 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K160211 (Trigg Laboratories D/B/A Wet International, 2016) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K051295.
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?
JO H2O Personal Lubricant is a water-based 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, polyurethane, and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150480: JO H20 Water Based Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150480
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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