510(k) · Cleared
ClearedAstroglide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · KMJ Lubricant, Patient
Cleared on Feb 18, 1994 as substantially equivalent to K810310 (Johnson & Johnson Professionals, Inc., 1981) after a 108-day review. Its family tree reaches back 1 generation to 1981. 120 later devices descend from it.
- Decided
- Feb 18, 1994
- Review
- 108 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K810310 (1981). 120 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- This deviceK935299 AstroglideBiofilm, Inc. · 1994
- Descendant · cites it directly · 40 of its ownK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- Descendant · cites it directly · 40 of its ownK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- Descendant · cites it directly · 27 of its ownK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
- Descendant · cites it directly · 24 of its ownK061466 IntimolDlc Laboratories, Inc. · 2006
- Descendant · cites it directly · 24 of its ownK042563 Durex Play Warmer LubricantSsl Americas, Inc. · 2005
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K072647Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008 · cites it directly40descendants
- K032124Durex Play LubricantSsl Americas, Inc. · 2004 · cites it directly40descendants
- K062682CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007 · cites it directly27descendants
- K061466IntimolDlc Laboratories, Inc. · 2006 · cites it directly24descendants
- K042563Durex Play Warmer LubricantSsl Americas, Inc. · 2005 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| 0 (this device) | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| +1 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| +1 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| +1 | K062682 | CVS Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | 2007 | — |
| +1 | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| +1 | K042563 | Durex Play Warmer Lubricant | Ssl Americas, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 11 | 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 KMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K810310 | K-Y Lubricating JellySummary page 3…lubricant. Sy L - 4Na7329 /4409 /va4 hi L % CLASSIFICATION NAME: Patient lubricant. PREDICATE DEVICE: K-Y Lubricating Jelly and Personal Lubricant, not sterilized, K810310. DESCRIPTION OF DEVICE: Astroglide is a clear, odorless, colorless personal lubricant composed of purified water, polyquaternium… | 1981 |
What descends from it? (120)
See all 12012 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072647 | Glycerin & Paraben Free Astroglide | 2008 | 40 |
| K032124 | Durex Play Lubricant | 2004 | 40 |
| K062682 | CVS Personal Lubricant and Moisturizer | 2007 | 27 |
| K061466 | Intimol | 2006 | 24 |
| K042563 | Durex Play Warmer Lubricant | 2005 | 24 |
| K060098 | Durex Play Temptations Assorted Lubricants | 2006 | 22 |
| K033076 | Lifestyles Liquid Personal Lubricant | 2003 | 17 |
| K063385 | Durex Play Massage Gel Lubricant | 2008 | 0 |
| K060145 | FDS Intimate and Intimate Warming Lubricant | 2006 | 0 |
| K042958 | Durex Play Tingling Lubricant | 2005 | 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?
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KMJ
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMJ
1in 2025
MAUDE reports naming product code KMJ, 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 | 0 | — | 0 | 5 |
| 2008 | 3 | 86 | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 1 | — | 12 | 7 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 1 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Personal lubrication and lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices used in medical procedures.
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/K935299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935299: Astroglide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935299
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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