510(k) · Cleared
ClearedWet Light Personal Moisturizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trigg Laboratories, Inc. · HIS Condom
Cleared on Dec 13, 2001 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 31 later devices descend from it.
- Decided
- Dec 13, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK013086 Wet Light Personal MoisturizerTrigg Laboratories, Inc. · 2001
- Descendant · cites it directly · 24 of its ownK061466 IntimolDlc Laboratories, Inc. · 2006
- Descendant · 2 generations on · 23 of its ownK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK142726 O Glide Personal LubricantGrafenberg Labs · 2015
- Descendant · cites it directly · 5 of its ownK110691 One Personal Lubricant (Water Based)One · 2012
- Descendant · 4 generations on · 4 of its ownK171985 Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K061466IntimolDlc Laboratories, Inc. · 2006 · cites it directly24descendants
- K124044Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013 · 2 generations on23descendants
- K142726O Glide Personal LubricantGrafenberg Labs · 2015 · 3 generations on5descendants
- K110691One Personal Lubricant (Water Based)One · 2012 · cites it directly5descendants
- K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013086 | Wet Light Personal Moisturizer | Trigg Laboratories, Inc. | 2001 | — |
| +1 | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| +2 | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | Seven Oaks Ranch, Inc. | 2013 | — |
| +3 | K142726 | O Glide Personal Lubricant | Grafenberg Labs | 2015 | — |
| +1 | K110691 | One Personal Lubricant (Water Based) | One | 2012 | — |
| +4 | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Biofilm, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIS? 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 HIS device
- #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.3 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (31)
See all 312 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?
- Of its descendants, K061466 (Dlc Laboratories, Inc., 2006) has gone furthest, with 24 descendants of its own.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 2025
MAUDE reports naming product code HIS, 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 | 7 | 128 | 1 | 10 |
| 2008 | 3 | 157 | 0 | 11 |
| 2009 | 5 | 241 | 0 | 12 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 3 | 54 | 0 | 15 |
| 2012 | 7 | 106 | 1 | 10 |
| 2013 | 4 | 208 | 1 | 19 |
| 2014 | 7 | 242 | 0 | 16 |
| 2015 | 3 | 136 | 0 | 8 |
| 2016 | 5 | 115 | 0 | 5 |
| 2017 | 4 | 102 | 0 | 8 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 4 | 240 | 0 | 12 |
| 2021 | 5 | 233 | 0 | 16 |
| 2022 | 10 | 112 | 0 | 18 |
| 2023 | 2 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 5 | 99 | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
WET® Light Personal Moisturizer is intended for over-the-counter use. It is used to supplement personal moisture in the vaginal area to enhance sexual pleasure. It is further used for lubricating latex condoms, and for easy insertion of rectal thermometers, tampons, douche and enema nozzles.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013086: Wet Light Personal Moisturizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013086
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026