510(k) · Cleared
ClearedDurex Ultra Comfort
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
London Intl., LLC · HIS Condom
Cleared on May 20, 1998 after a 113-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- May 20, 1998
- Review
- 113 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK980319 Durex Ultra ComfortLondon Intl., LLC · 1998
- Descendant · cites it directly · 1 of its ownK042957 Durex Male Latex Condom with Warming LubricantSsl Americas · 2005
- Descendant · cites it directly · 1 of its ownK040185 Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 2004
- Descendant · cites it directly · 0 of its ownK131866 SustainHollender Sustainable Brands, LLC · 2014
- Descendant · cites it directly · 0 of its ownK072169 Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK051273 Divas Dual Pleasure Male Latex CondomEagle Twe, Inc. · 2005
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042957Durex Male Latex Condom with Warming LubricantSsl Americas · 2005 · cites it directly1descendant
- K040185Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 2004 · cites it directly1descendant
- K131866SustainHollender Sustainable Brands, LLC · 2014 · cites it directly0descendants
- K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 2008 · cites it directly0descendants
- K051273Divas Dual Pleasure Male Latex CondomEagle Twe, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980319 | Durex Ultra Comfort | London Intl., LLC | 1998 | — |
| +1 | K042957 | Durex Male Latex Condom with Warming Lubricant | Ssl Americas | 2005 | — |
| +1 | K040185 | Durex Studded/Ribbed Lubricated Latex Condom | Ssl Americas | 2004 | — |
| +1 | K131866 | Sustain | Hollender Sustainable Brands, LLC | 2014 | — |
| +1 | K072169 | Durex Synthetic Polyisoprene Male Condom | Ssl Americas, Inc. | 2008 | 4 |
| +2 | K051273 | Divas Dual Pleasure Male Latex Condom | Eagle Twe, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042957 | Durex Male Latex Condom with Warming Lubricant | 2005 | 1 |
| K040185 | Durex Studded/Ribbed Lubricated Latex Condom | 2004 | 1 |
| K131866 | Sustain | 2014 | 0 |
| K072169 | Durex Synthetic Polyisoprene Male Condom | 2008 | 0 |
| K042470 | Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' Condom | 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?
- Of its descendants, K042957 (Ssl Americas, 2005) has gone furthest, with 1 descendant of its own.
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?
A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980319: Durex Ultra Comfort.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980319
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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