510(k) · Cleared
ClearedLifestyles Zero Lubricated Latex Male Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · HIS Condom
Cleared on Jan 23, 2017 as substantially equivalent to K941258 (Suretex, Ltd., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Jan 23, 2017
- Review
- 77 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941258 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941258 Latex CondomSuretex, Ltd. · 1995 · Recalled
- This deviceK163107 Lifestyles Zero Lubricated Latex Male CondomAnsell Healthcare Products, LLC · 2017
- Descendant · cites it directly · 3 of its ownK200672 Durex Penck Standard, Durex Penck XLRb Health (Us), LLC · 2020
- Descendant · 2 generations on · 1 of its ownK213647 Durex Patronus WideRb Health (Us), LLC · 2022
- Descendant · cites it directly · 0 of its ownK252521 LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited · 2025
- Descendant · 3 generations on · 0 of its ownK220489 Durex Patronus CloseFit, Durex Patronus RegularRb Health (Us), LLC · 2022
- Descendant · 2 generations on · 0 of its ownK222068 Durex Penck III RegularRb Health (Us), LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K200672Durex Penck Standard, Durex Penck XLRb Health (Us), LLC · 2020 · cites it directly3descendants
- K213647Durex Patronus WideRb Health (Us), LLC · 2022 · 2 generations on1descendant
- K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited · 2025 · cites it directly0descendants
- K220489Durex Patronus CloseFit, Durex Patronus RegularRb Health (Us), LLC · 2022 · 3 generations on0descendants
- K222068Durex Penck III RegularRb Health (Us), LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941258 | Latex Condom | Suretex, Ltd. | 1995 | 1 |
| 0 (this device) | K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | 2017 | — |
| +1 | K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | 2020 | — |
| +2 | K213647 | Durex Patronus Wide | Rb Health (Us), LLC | 2022 | — |
| +1 | K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | 2025 | — |
| +3 | K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | 2022 | — |
| +2 | K222068 | Durex Penck III Regular | Rb Health (Us), LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K941258 | Latex CondomSummary page 4…HIS; condom Classification Panel: Obstetrics/Gynecology Classification Name: Condom Reason for 510(k) Submission: New product. Predicate Device: K941258 – Latex Condom with Silicone Oil Lubricant. The predicate device has not been subject to a design related recall.… | 1995 |
What descends from it? (5)
2 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)
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. 2017, this device’s year, is highlighted.
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 Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163107: Lifestyles Zero Lubricated Latex Male Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163107
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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