510(k) · Cleared
ClearedAstroglide Natural
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · NUC Lubricant, Personal
Cleared on Aug 6, 2014 as substantially equivalent to K072647 (Biofilm, Inc., 2008) after a 54-day review. Its family tree reaches back 3 generations to 1981. 7 later devices descend from it.
- Decided
- Aug 6, 2014
- Review
- 54 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K810310 (1981). 4 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 1 generation backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- This deviceK141581 Astroglide NaturalBiofilm, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK200114 Astroglide Organix LiquidBiofilm, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK200731 pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur…Pjur Group Luxembourg S.A. · 2021
- Descendant · 3 generations on · 1 of its ownK240081 Human LubricantJiangxi Wulinxiang Biological Technology Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK251773 Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor…Shenzhen Yongquan Medical Devices Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200239 Astroglide Organix GelBiofilm, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200114Astroglide Organix LiquidBiofilm, Inc. · 2020 · cites it directly3descendants
- K200731pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal…Pjur Group Luxembourg S.A. · 2021 · 2 generations on2descendants
- K240081Human LubricantJiangxi Wulinxiang Biological Technology Co., Ltd. · 2024 · 3 generations on1descendant
- K251773Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel…Shenzhen Yongquan Medical Devices Co., Ltd. · 2025 · 4 generations on0descendants
- K200239Astroglide Organix GelBiofilm, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −2 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −1 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| 0 (this device) | K141581 | Astroglide Natural | Biofilm, Inc. | 2014 | — |
| +1 | K200114 | Astroglide Organix Liquid | Biofilm, Inc. | 2020 | — |
| +2 | K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR… | Pjur Group Luxembourg S.A. | 2021 | — |
| +3 | K240081 | Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. | 2024 | — |
| +4 | K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin… | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025 | — |
| +1 | K200239 | Astroglide Organix Gel | Biofilm, Inc. | 2020 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K072647 | Glycerin & Paraben Free AstroglideSummary page 4…sonal, 21 CFR 884.5300 Condom, Product Code: NUC Predicate Device Predicate Device 510(k) Number Glycerin and Paraben Free Astroglide Original Applicant: BioFilm, Inc. K072647 Description of Device Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a pro… | 2008 |
What descends from it? (7)
4 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 33 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200114 (Biofilm, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K072647.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141581: Astroglide Natural.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141581
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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