510(k) · Cleared
Recalled · Class II · 2012Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretex, Ltd. · HIS Condom
Cleared on Dec 6, 1995 after a 630-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it. It has been recalled once.
- Decided
- Dec 6, 1995
- Review
- 630 days
- Class
- Class II
- Product code
- HIS
- Recalls
- 1
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK941258 Latex CondomSuretex, Ltd. · 1995
- Descendant · cites it directly · 5 of its ownK163107 Lifestyles Zero Lubricated Latex Male CondomAnsell Healthcare Products, LLC · 2017
- Descendant · cites it directly · 5 of its ownK070800 Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC · 2008
- Descendant · 2 generations on · 4 of its ownK160399 Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK200672 Durex Penck Standard, Durex Penck XLRb Health (Us), LLC · 2020
- Descendant · 3 generations on · 1 of its ownK213647 Durex Patronus WideRb Health (Us), LLC · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K163107Lifestyles Zero Lubricated Latex Male CondomAnsell Healthcare Products, LLC · 2017 · cites it directly5descendants
- K070800Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC · 2008 · cites it directly5descendants
- K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016 · 2 generations on4descendants
- K200672Durex Penck Standard, Durex Penck XLRb Health (Us), LLC · 2020 · 2 generations on3descendants
- K213647Durex Patronus WideRb Health (Us), LLC · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941258 | Latex Condom | Suretex, Ltd. | 1995 | — |
| +1 | K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | 2017 | — |
| +1 | K070800 | Lifestyles Lubricated Polyisoprene Latex Male Condom | Ansell Healthcare Products, LLC | 2008 | — |
| +2 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016 | 1 |
| +2 | K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | 2020 | — |
| +3 | K213647 | Durex Patronus Wide | Rb Health (Us), LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2012 | Class II | Z-0717-2013 | Packaging | One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163107 (Ansell Healthcare Products, LLC, 2017) has gone furthest, with 5 descendants 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 | — |
https://510kreport.com/device/K941258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941258: 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/K941258
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026