510(k) · Cleared
ClearedVielle Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cst Medical Limited · HIS Condom
Cleared on Feb 3, 2006 as substantially equivalent to K033776 (Instead, Inc., 2004) and 1 other predicate after a 261-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 3, 2006
- Review
- 261 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K903910 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 2 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 1 generation backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- This deviceK051288 Vielle LubricantCst Medical Limited · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −2 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −1 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| 0 (this device) | K051288 | Vielle Lubricant | Cst Medical Limited | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K033776 | Instead Intimate LubricantSummary page 1…Lubricant 3. Classification Name: Lubricant (21 CFR 884.5300) 4. Predicate Device: Instead, Inc. Instead Intimate Lubricant K033776 Qualis, Inc. Personal Lubricating Gel K041129 5. Intended Use: VielleTM person… | 2004 |
| * | K041129 | Personal Lubricating GelSummary page 1…5300) 4. Predicate Device: Instead, Inc. Instead Intimate Lubricant K033776 Qualis, Inc. Personal Lubricating Gel K041129 5. Intended Use: VielleTM personal lubricant is intended for personal lubrication, lubrication… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K033776.
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?
VielleTM personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051288: Vielle Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051288
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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