510(k) · Cleared
ClearedLifestyles Liquid Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare, Inc. · HIS Condom
Cleared on Dec 19, 2003 as substantially equivalent to K935299 (Biofilm, Inc., 1994) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1981. 17 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810310 (1981). 3 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 1 generation backK935299 AstroglideBiofilm, Inc. · 1994
- This deviceK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- Descendant · cites it directly · 11 of its ownK070587 Elegance Woman's LubricantJulie Williams, Pa-C · 2008
- Descendant · 2 generations on · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · 3 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK051688 For Play, Slip, Prepair - Personal LubricantsTrimensa Pharmaceuticals · 2006
- Descendant · 2 generations on · 2 of its ownK110325 Aqua LubeMayer Laboratories, Inc. · 2011
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070587Elegance Woman's LubricantJulie Williams, Pa-C · 2008 · cites it directly11descendants
- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · 2 generations on9descendants
- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 3 generations on6descendants
- K051688For Play, Slip, Prepair - Personal LubricantsTrimensa Pharmaceuticals · 2006 · cites it directly3descendants
- K110325Aqua LubeMayer Laboratories, Inc. · 2011 · 2 generations on2descendants
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) | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| +1 | K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | 2008 | — |
| +2 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +3 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +1 | K051688 | For Play, Slip, Prepair - Personal Lubricants | Trimensa Pharmaceuticals | 2006 | — |
| +2 | K110325 | Aqua Lube | Mayer Laboratories, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 HIS? 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 HIS device
- #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.3 · 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 |
|---|---|---|---|
| * | K935299 | AstroglideSummary page 1…Personal Lubricant Classification Name: Condom (21 CFR §884.5300) Product Code 85HIS Predicate Device: Astroglide® Personal Lubricant (K935299) K-Y® Liquid Personal Lubricant (K955648) Description of the Device: LifeStyles® Liquid Personal Lubri… | 1994 |
| * | K955648 | K-Y Personal LubricantSummary page 1…00) Product Code 85HIS Predicate Device: Astroglide® Personal Lubricant (K935299) K-Y® Liquid Personal Lubricant (K955648) Description of the Device: LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to s… | 1996 |
What descends from it? (17)
See all 173 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 22 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070587 (Julie Williams, Pa-C, 2008) has gone furthest, with 11 descendants of its own.
- 11 other devices also cite its predicate K935299.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 2025
MAUDE reports naming product code HIS, 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 | 7 | 128 | 1 | 10 |
| 2008 | 3 | 157 | 0 | 11 |
| 2009 | 5 | 241 | 0 | 12 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 3 | 54 | 0 | 15 |
| 2012 | 7 | 106 | 1 | 10 |
| 2013 | 4 | 208 | 1 | 19 |
| 2014 | 7 | 242 | 0 | 16 |
| 2015 | 3 | 136 | 0 | 8 |
| 2016 | 5 | 115 | 0 | 5 |
| 2017 | 4 | 102 | 0 | 8 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 4 | 240 | 0 | 12 |
| 2021 | 5 | 233 | 0 | 16 |
| 2022 | 10 | 112 | 0 | 18 |
| 2023 | 2 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 5 | 99 | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033076: Lifestyles Liquid 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/K033076
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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