510(k) · Cleared
ClearedJust Between US, Personal Lubricant & Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Key West Fragrance & Cosmetic · HIS Condom
Cleared on Oct 29, 1998 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1990. 18 later devices descend from it.
- Decided
- Oct 29, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903910 (1990). 2 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- This deviceK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- Descendant · cites it directly · 17 of its ownK033776 Instead Intimate LubricantInstead, Inc. · 2004
- Descendant · 2 generations on · 15 of its ownK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- Descendant · 4 generations on · 9 of its ownK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- Descendant · 5 generations on · 6 of its ownK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K033776Instead Intimate LubricantInstead, Inc. · 2004 · cites it directly17descendants
- K051295I-D GlideWestridge Laboratories, Inc. · 2006 · 2 generations on15descendants
- K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015 · 3 generations on12descendants
- K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016 · 4 generations on9descendants
- K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…United Consortium · 2019 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| 0 (this device) | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| +1 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| +2 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| +3 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| +4 | K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | 2016 | — |
| +5 | K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant… | United Consortium | 2019 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 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 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 13.2 · 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 |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 1…the following legally manufactured and marketed devices. e K-Y® Brand Liquid™ Personal Lubricant manufactured by Ortho Phar- maceutical Corporation pursuant to 510(k) K955648 e WonderGel® Personal Liquid Gel manufactured by Lake Consumer Prod- ucts, Inc. pursuant to 510(k) K903910 Device Description… | 1996 |
| * | K903910 | Lubricating JellySummary page 1…ed by Ortho Phar- maceutical Corporation pursuant to 510(k) K955648 e WonderGel® Personal Liquid Gel manufactured by Lake Consumer Prod- ucts, Inc. pursuant to 510(k) K903910 Device Description The Just Between Us™ Personal Lubricant and Condom kit is a non-sterile convenience kit that provides a late… | 1990 |
| † | K910550 | Condoms/Saxon, Gold Circle Coin, Embrace & Rainbow | 1991 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033776 | Instead Intimate Lubricant | 2004 | 17 |
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 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?
The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
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/K982673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982673: Just Between US, Personal Lubricant & Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982673
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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