510(k) · Cleared
ClearedLUBi Water Based Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boya Biotechnology Co., Ltd. · NUC Lubricant, Personal
Cleared on Dec 23, 2020 as substantially equivalent to K200208 (CC Wellness, LLC, 2020) after a 49-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Dec 23, 2020
- Review
- 49 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K903910 (1990). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 7 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 6 generations backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- 5 generations backK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- 4 generations backK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- 3 generations backK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- 2 generations backK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
- 1 generation backK200208 Agape Warming Personal LubricantCC Wellness, LLC · 2020
- This deviceK203257 LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK210857 Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210857Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −7 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −6 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| −5 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| −4 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| −3 | 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 | — |
| −1 | K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | 2020 | — |
| 0 (this device) | K203257 | LUBi Water Based Personal Lubricant | Boya Biotechnology Co., Ltd. | 2020 | — |
| +1 | K210857 | Personal Lubricant | Shenzhen Huanqiu Xuebao Technology Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200208 | Agape Warming Personal LubricantSummary page 4…ice Trade Name Agape Warming Personal Lubricant Manufacturer CC Wellness LLC 510(k) Number K200208 Common name: Personal Lubricant Regulation Number 884.5300 Regula… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210857 | Personal Lubricant | 2021 | 0 |
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 30 years and passes through 9 companies; a new generation was cleared every 2.9 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K210857 (Shenzhen Huanqiu Xuebao Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K200208.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
LUBi Water Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203257: LUBi 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/K203257
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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