510(k) · Cleared
ClearedWater-soluble Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Pingchuang Medical Technology Co., Ltd. · NUC Lubricant, Personal
Cleared on Nov 18, 2021 as substantially equivalent to K200208 (CC Wellness, LLC, 2020) after a 135-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Nov 18, 2021
- Review
- 135 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. No later device cites it as a predicate yet.
- 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 deviceK212104 Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd. · 2021
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) | K212104 | Water-soluble Personal Lubricant | Foshan Pingchuang Medical 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 |
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…: Class II 5. Predicate Device Information Device Name: Agape Warming Personal Lubricant 510(k) Number: K200208 Manufacturer: CC Wellness LLC The predicate device has not been subject to a design-related recall.… | 2020 |
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 31 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.
- 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. 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?
Water-soluble Personal Lubricant is a personal lubricant for penile, anal 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/K212104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212104: Water-soluble 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/K212104
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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