510(k) · Cleared
ClearedIntimol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dlc Laboratories, Inc. · NUC Lubricant, Personal
Cleared on Dec 4, 2006 as substantially equivalent to K013086 (Trigg Laboratories, Inc., 2001) and 2 other predicates after a 192-day review. Its family tree reaches back 2 generations to 1981. 24 later devices descend from it.
- Decided
- Dec 4, 2006
- Review
- 192 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K810310 (1981). 4 ancestors in all. 24 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 1 generation backK935299 AstroglideBiofilm, Inc. · 1994
- This deviceK061466 IntimolDlc Laboratories, Inc. · 2006
- Descendant · cites it directly · 23 of its ownK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK142726 O Glide Personal LubricantGrafenberg Labs · 2015
- Descendant · 3 generations on · 4 of its ownK171985 Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK141034 Azul Personal LubricantChurch & Dwight Co., Inc. · 2014
- Descendant · 4 generations on · 2 of its ownK222175 Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K124044Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013 · cites it directly23descendants
- K142726O Glide Personal LubricantGrafenberg Labs · 2015 · 2 generations on5descendants
- K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017 · 3 generations on4descendants
- K141034Azul Personal LubricantChurch & Dwight Co., Inc. · 2014 · 2 generations on3descendants
- K222175Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −1 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| 0 (this device) | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| +1 | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | Seven Oaks Ranch, Inc. | 2013 | — |
| +2 | K142726 | O Glide Personal Lubricant | Grafenberg Labs | 2015 | — |
| +3 | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Biofilm, Inc. | 2017 | — |
| +2 | K141034 | Azul Personal Lubricant | Church & Dwight Co., Inc. | 2014 | — |
| +4 | K222175 | Bloomi Delight Oil-Based Personal Lubricant | The Bloomi Inc.. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K013086 | Wet Light Personal Moisturizer | 2001 |
| * | K935299 | AstroglideSummary page 1…condoms (21 CFR §884.5300) Predicate Device: Wet® Light Personal Moisturizer (KO13086) Astroglide® Personal Lubricant (K935299) K-Y® Liquid Personal Lubricant (K955648) Intended Use: INTIMOLTM Liquid Personal lubricant is… | 1994 |
| * | K955648 | K-Y Personal LubricantSummary page 1…Wet® Light Personal Moisturizer (KO13086) Astroglide® Personal Lubricant (K935299) K-Y® Liquid Personal Lubricant (K955648) Intended Use: INTIMOLTM Liquid Personal lubricant is principally intended as personal lubrica… | 1996 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | 2013 | 23 |
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 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K124044 (Seven Oaks Ranch, Inc., 2013) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K013086.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
INTIMOLTM Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061466: Intimol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061466
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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