510(k) · Cleared
ClearedDurex Latex Condom with Male Genital Desensitizer Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas, Inc. · HIS Condom
Cleared on Mar 29, 2002 as substantially equivalent to K952415 (London International U.S. Holdings, Inc., 1996) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.
- Decided
- Mar 29, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K822088 (1982). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK822088 Male CondomSchmid Laboratories, Inc. · 1982
- This deviceK020659 Durex Latex Condom with Male Genital Desensitizer LubricantSsl Americas, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK211152 Durex Condom with BenzocaineRb Health (Us), LLC · 2022
- Descendant · 2 generations on · 0 of its ownK230049 SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian…Ttk Healthcare Limited · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822088 | Male Condom | Schmid Laboratories, Inc. | 1982 | — |
| 0 (this device) | K020659 | Durex Latex Condom with Male Genital Desensitizer Lubricant | Ssl Americas, Inc. | 2002 | — |
| +1 | K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | 2022 | — |
| +2 | K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate… | Ttk Healthcare Limited | 2023 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K952415 | Durex, Ramses, SheikSummary page 1…ex condom with male desensitizer lubricant Common Name: Latex Condom Classification Name: Condom (21 CFR § 884.5300) Predicate Device: DUREX" Hispano Ico Latex Condom (K952415) and Male Condom with Desensitizer (K822088) Description of the Device: DUREX Latex Condom with Male Genital Desensitizer Lubri… | 1996 |
| * | K822088 | Male CondomSummary page 1…mmon Name: Latex Condom Classification Name: Condom (21 CFR § 884.5300) Predicate Device: DUREX" Hispano Ico Latex Condom (K952415) and Male Condom with Desensitizer (K822088) Description of the Device: DUREX Latex Condom with Male Genital Desensitizer Lubricant is made of a natural rubber latex sheath… | 1982 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211152 | Durex Condom with Benzocaine | 2022 | 1 |
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 DUREX® Latex Condom with Male Genital Desensitizer Lubricant is used
for contraception and for prophylactic purposes to help reduce the risk of
pregnancy and the transmission of sexually transmitted diseases. The male
genital desensitizer lubricant on the condom helps in temporarily prolonging
the time until ejaculation.
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/K020659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020659: Durex Latex Condom with Male Genital Desensitizer Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020659
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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