510(k) · Cleared
ClearedCVS Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
San-Mar Laboratories, Inc. · HIS Condom
Cleared on May 17, 1999 after a 245-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 19 later devices descend from it.
- Decided
- May 17, 1999
- Review
- 245 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
19 later devices descend from it, 2 citing it directly.
- This deviceK983216 CVS Personal LubricantSan-Mar Laboratories, Inc. · 1999
- 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 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K983216 | CVS Personal Lubricant | San-Mar Laboratories, Inc. | 1999 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 13.3 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K935291 | Astroglide Personal Lubricant Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ARY NAME: CVS PERSONAL LUBRICANT COMMON/USUAL NAME: Personal Lubricant CLASSIFICATION NAME: Patient Lubricant-Class | PREDICATE DEVICE: Astroglide Personal Lubricant, K935291 DESCRIPTION OF DEVICE: “CVS Personal Lubricant” is a clear , colorless and odorless personal lubricant, which is composed of the… |
What descends from it? (19)
See all 192 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?
- Of its descendants, K033776 (Instead, Inc., 2004) has gone furthest, with 17 descendants of its own.
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?
Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.
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/K983216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983216: CVS 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/K983216
Report an extraction error
Are you the manufacturer?
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