510(k) · Cleared
ClearedGlycerin & Paraben Free Astroglide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · NUC Lubricant, Personal
Cleared on Jan 25, 2008 as substantially equivalent to K020586 (Biofilm, Inc., 2003) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 1981. 40 later devices descend from it.
- Decided
- Jan 25, 2008
- Review
- 128 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810310 (1981). 3 ancestors in all. 40 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 1 generation backK935299 AstroglideBiofilm, Inc. · 1994
- This deviceK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- Descendant · cites it directly · 19 of its ownK094039 Hyalo GynFidia Farmaceutici S.P.A. · 2010
- Descendant · 2 generations on · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · cites it directly · 7 of its ownK141581 Astroglide NaturalBiofilm, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK130345 Aqua Lube Natural Lubricant - Regular, WarmingMayer Laboratories, Inc. · 2013
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K094039Hyalo GynFidia Farmaceutici S.P.A. · 2010 · cites it directly19descendants
- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · 2 generations on9descendants
- K141581Astroglide NaturalBiofilm, Inc. · 2014 · cites it directly7descendants
- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 3 generations on6descendants
- K130345Aqua Lube Natural Lubricant - Regular, WarmingMayer Laboratories, Inc. · 2013 · cites it directly6descendants
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) | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| +1 | K094039 | Hyalo Gyn | Fidia Farmaceutici S.P.A. | 2010 | — |
| +2 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +1 | K141581 | Astroglide Natural | Biofilm, Inc. | 2014 | — |
| +3 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +1 | K130345 | Aqua Lube Natural Lubricant - Regular, Warming | Mayer Laboratories, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | K020586 | Good LubricationsSummary page 1…Condom, (21 CFR 884.5300) MMS - Patient Lubricant (21 CFR 880.6375) Predicate Device Good Lubrications Personal Lubricant (K020586) Description of Device Glycerin & Paraben Free Astroglide~ is a non-sterile, clear, non-greasy, high viscosity liquid used as a… | 2003 |
| * | K935299 | AstroglideSummary page 1…n shown in laboratory testing to be substantially equivalent to the currently marketed Good Lubrications Personal Lubricant (K020586) and Astroglidle Personal Lubricant (K935299). Both devices have the same intended use and similar formulation.… | 1994 |
What descends from it? (40)
See all 406 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?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 13.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K094039 (Fidia Farmaceutici S.P.A., 2010) has gone furthest, with 19 descendants of its own.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, 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 latex condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072647 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072647: Glycerin & Paraben Free Astroglide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072647
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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