510(k) · Cleared
ClearedDurex Lubragel Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
London Intl., LLC · HIS Condom
Cleared on Nov 16, 1998 as substantially equivalent to K952415 (London International U.S. Holdings, Inc., 1996) after a 52-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.
- Decided
- Nov 16, 1998
- Review
- 52 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952415 (1996). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- This deviceK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- Descendant · cites it directly · 7 of its ownK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- Descendant · 3 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · 4 generations on · 1 of its ownK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled
- Descendant · 4 generations on · 1 of its ownK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032227Durex Flavored Latex CondomSsl Americas, Inc. · 2004 · cites it directly7descendants
- K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008 · 2 generations on6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 3 generations on5descendants
- K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · 4 generations on1descendant
- K111093Billy Boy Male Latex CondomMapa GmbH · 2011 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| 0 (this device) | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| +1 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| +2 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| +3 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +4 | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | 1 |
| +4 | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952415 | Durex, Ramses, SheikSummary page 1…y Name: Durex Lubragel Male Latex Condom Common Name: Latex Condom Classification Name: Condom (21 CFR Section 844.5300) Predicate Device: Latex Lubncated Condom 510(k) K952415 Description of the Device This condom is made of a natural rubber latex sheath, which completely covers the peni… | 1996 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032227 | Durex Flavored Latex Condom | 2004 | 7 |
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 Condom is used for contraception and for Prophylactic
purposes (to help prevent pregnancy and the transmission of sexually
transmitted diseases).
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/K983380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983380: Durex Lubragel 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/K983380
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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