510(k) · Cleared
ClearedAstroglide Diamond Silicone Gel Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · NUC Lubricant, Personal
Cleared on Feb 10, 2017 as substantially equivalent to K110690 (One, 2012) after a 67-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Feb 10, 2017
- Review
- 67 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062796 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK062796 K-Y Brand IntriguePersonal Products Co. · 2006
- 1 generation backK110690 One Personal Lubricant (Silicone)One · 2012
- This deviceK163395 Astroglide Diamond Silicone Gel Personal LubricantBiofilm, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK191214 JO Premium Jelly Original Personal LubricantUnited Consortium · 2019
Most influential descendants
Showing 1 of 1 · See all- K191214JO Premium Jelly Original Personal LubricantUnited Consortium · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062796 | K-Y Brand Intrigue | Personal Products Co. | 2006 | — |
| −1 | K110690 | One Personal Lubricant (Silicone) | One | 2012 | — |
| 0 (this device) | K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Biofilm, Inc. | 2017 | — |
| +1 | K191214 | JO Premium Jelly Original Personal Lubricant | United Consortium | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K110690 | One Personal Lubricant (Silicone)Summary page 4…Predicate Device 510(k) Number ONE® SILICONE Personal Lubricant K110690 Original Applicant: ONE® This predicate device has never been the subject of a device recall. iv. D… | 2012 |
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 |
|---|---|---|---|
| K191214 | JO Premium Jelly Original Personal Lubricant | 2019 | 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 11 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K191214 (United Consortium, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K110690.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Astroglide® Diamond Silicone Gel 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, polyurethane, and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163395: Astroglide Diamond Silicone Gel Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163395
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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