510(k) · Cleared
ClearedGood Lubrications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · KMJ Lubricant, Patient
Cleared on Jan 24, 2003 after a 336-day review. The FDA summary names no predicate by number. 41 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 336 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 1 citing it directly.
- This deviceK020586 Good LubricationsBiofilm, Inc. · 2003
- Descendant · cites it directly · 40 of its ownK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- Descendant · 2 generations on · 19 of its ownK094039 Hyalo GynFidia Farmaceutici S.P.A. · 2010
- Descendant · 3 generations on · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · 2 generations on · 7 of its ownK141581 Astroglide NaturalBiofilm, Inc. · 2014
- Descendant · 4 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K072647Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008 · cites it directly40descendants
- K094039Hyalo GynFidia Farmaceutici S.P.A. · 2010 · 2 generations on19descendants
- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · 3 generations on9descendants
- K141581Astroglide NaturalBiofilm, Inc. · 2014 · 2 generations on7descendants
- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020586 | Good Lubrications | Biofilm, Inc. | 2003 | — |
| +1 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| +2 | K094039 | Hyalo Gyn | Fidia Farmaceutici S.P.A. | 2010 | — |
| +3 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +2 | K141581 | Astroglide Natural | Biofilm, Inc. | 2014 | — |
| +4 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 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?
The FDA summary names no predicate by number.
What descends from it? (41)
See all 411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072647 | Glycerin & Paraben Free Astroglide | 2008 | 40 |
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?
- Of its descendants, K072647 (Biofilm, Inc., 2008) has gone furthest, with 40 descendants of its own.
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?
Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.
Good lubrications may be used with condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020586: Good Lubrications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020586
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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