510(k) · Cleared
ClearedDurex Flavored Latex Condom
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, 2004 as substantially equivalent to K020633 (Ls Rubber Sdn Bhd, 2002) and 2 other predicates after a 252-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it.
- Decided
- Mar 29, 2004
- Review
- 252 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952415 (1996). 5 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 1 generation backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- This deviceK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- Descendant · 2 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · 3 generations on · 1 of its ownK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
- Descendant · 4 generations on · 0 of its ownK153016 aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008 · cites it directly6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 2 generations on5descendants
- K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · 3 generations on1descendant
- K111093Billy Boy Male Latex CondomMapa GmbH · 2011 · 3 generations on1descendant
- K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −1 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| 0 (this device) | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| +1 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| +2 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +3 | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | 1 |
| +3 | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
| +4 | K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K020633 | Natural and Colored Latex Condom with FlavorsSummary page 1…Latex Condom E. Common Name Latex Condom F. Classification Name Condom (21 CFR 884.5300) G. Predicated Device Natural and Colored Condoms with Flavors [510(k) Number K020633] One Touch (or private label) Flavored Male Latex Condom [51 0(k) Number K01 1253] Durex Lubragel Latex Rubber Condom [510(k) Num… | 2002 |
| * | K011253 | Flavored Male Latex CondomSummary page 1…884.5300) G. Predicated Device Natural and Colored Condoms with Flavors [510(k) Number K020633] One Touch (or private label) Flavored Male Latex Condom [51 0(k) Number K01 1253] Durex Lubragel Latex Rubber Condom [510(k) Number K983380] H. Description of the Device This condom is made of a natural rubber… | 2001 |
| * | K983380 | Durex Lubragel Latex CondomSummary page 1…with Flavors [510(k) Number K020633] One Touch (or private label) Flavored Male Latex Condom [51 0(k) Number K01 1253] Durex Lubragel Latex Rubber Condom [510(k) Number K983380] H. Description of the Device This condom is made of a natural rubber colored latex sheath, which completely covers the penis wi… | 1998 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081413 | Twinlotus and Shields Natural Rubber Latex Condom | 2008 | 6 |
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 8 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K081413 (Dailian Latex Company, Ltd., 2008) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K020633.
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/K032227 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032227: Durex Flavored Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032227
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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