510(k) · Cleared
ClearedDurex Studded/Ribbed Lubricated Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas · HIS Condom
Cleared on Apr 27, 2004 as substantially equivalent to K012962 (Innolatex Sdn. Bhd, 2001) and 2 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Apr 27, 2004
- Review
- 91 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902509 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K041717Powerstick Male Latex CondomsA.P.Deauville, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902509 | Saxon Ribbed Condoms | Safetex Corp. | 1990 | — |
| 0 (this device) | K040185 | Durex Studded/Ribbed Lubricated Latex Condom | Ssl Americas | 2004 | — |
| +1 | K041717 | Powerstick Male Latex Condoms | A.P.Deauville, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K012962 | Dotted Condom, Male Natural Rubber Latex CondomSummary page 3…smitted diseases). J. Technological Characteristics This condom has the same technological characteristics as the predicate condoms identified. The condoms described in K012962 are manufactured of natural rubber latex with raised studs. The condoms described in K902509 are Durex manufactured ribbed Natura… | 2001 |
| * | K902509 | Saxon Ribbed CondomsSummary page 2…le Latex Condom F. Classification Name HiIS G. Predicated Device Dotted Condom [510(k) Number KO12962] Ribbed Condoms [510(k) Number K902509] Durex Latex Rubber Condom [510(k) Number K980319] H. Description of the Device This condom is made of a na… | 1990 |
| * | K980319 | Durex Ultra ComfortSummary page 2…S G. Predicated Device Dotted Condom [510(k) Number KO12962] Ribbed Condoms [510(k) Number K902509] Durex Latex Rubber Condom [510(k) Number K980319] H. Description of the Device This condom is made of a natural rubber latex sheath, which completely covers… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041717 | Powerstick Male Latex Condoms | 2005 | 0 |
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?
Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040185: Durex Studded/Ribbed Lubricated Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040185
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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