510(k) · Cleared
Recalled · Class II · 2022Skyn Original Polyisoprene Lubricated Male Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · MOL Condom, Synthetic
Cleared on Jul 25, 2016 as substantially equivalent to K070800 (Ansell Healthcare Products, LLC, 2008) after a 164-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2016
- Review
- 164 days
- Class
- Class II
- Product code
- MOL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941258 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK941258 Latex CondomSuretex, Ltd. · 1995 · Recalled
- 1 generation backK070800 Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC · 2008
- This deviceK160399 Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016
- Descendant · cites it directly · 1 of its ownK171172 Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC · 2017
- Descendant · cites it directly · 0 of its ownK232470 Polyisoprene Extra Large CondomSuretex Limited · 2024
- Descendant · cites it directly · 0 of its ownK231908 45 Micron Polyisoprene CondomSuretex Limited · 2023
- Descendant · 2 generations on · 0 of its ownK182438 Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC · 2017 · cites it directly1descendant
- K232470Polyisoprene Extra Large CondomSuretex Limited · 2024 · cites it directly0descendants
- K23190845 Micron Polyisoprene CondomSuretex Limited · 2023 · cites it directly0descendants
- K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941258 | Latex Condom | Suretex, Ltd. | 1995 | 1 |
| −1 | K070800 | Lifestyles Lubricated Polyisoprene Latex Male Condom | Ansell Healthcare Products, LLC | 2008 | — |
| 0 (this device) | K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016 | — |
| +1 | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017 | — |
| +1 | K232470 | Polyisoprene Extra Large Condom | Suretex Limited | 2024 | — |
| +1 | K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | 2023 | — |
| +2 | K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 MOL? 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 MOL device
- #1 K252158 Sagami Original 002 Polyurethane Male Condomscore 11.4 · 2 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 |
|---|---|---|---|
| * | K070800 | Lifestyles Lubricated Polyisoprene Latex Male CondomSummary page 4…ation: 21 CFR 884.5300 Device Class: Class II Product Code: MOL Classification Panel: Obstetrics/Gynecology Predicate Device: K070800 - Lifestyles Lubricated Polyisoprene Latex Male Condom Reason for 510(k) Submission: The subject device is a modified version of… | 2008 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Jun 23, 2022 | Class II | Z-1530-2022 | Storage | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K171172 (Ansell Healthcare Products, LLC, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MOL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOL
244in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOL
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOL
4in 2025
MAUDE reports naming product code MOL, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 2 | — | 0 | 9 |
| 2018 | 1 | — | 3 | 11 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 3 | 244 | 0 | 2 |
| 2025 | 2 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Skyn Original Polyisoprene Lubricated Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STI's).
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/K160399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160399: Skyn Original Polyisoprene Lubricated Male Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160399
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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