510(k) · Cleared
ClearedSkyn Original Polyisoprene Lubricated Male Condom - Flavored
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 Aug 2, 2017 as substantially equivalent to K160399 (Ansell Healthcare Products, LLC, 2016) after a 103-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Aug 2, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941258 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK941258 Latex CondomSuretex, Ltd. · 1995 · Recalled
- 2 generations backK070800 Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC · 2008
- 1 generation backK160399 Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016 · Recalled
- This deviceK171172 Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC · 2017
- Descendant · cites it directly · 0 of its ownK182438 Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941258 | Latex Condom | Suretex, Ltd. | 1995 | 1 |
| −2 | K070800 | Lifestyles Lubricated Polyisoprene Latex Male Condom | Ansell Healthcare Products, LLC | 2008 | — |
| −1 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016 | 1 |
| 0 (this device) | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017 | — |
| +1 | K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K160399 | Skyn Original Polyisoprene Lubricated Male CondomSummary page 4…21 CFR 884.5300 Device Class: Class II Product Code: MOL Classification Panel: Obstetrics/Gynecology Predicate Device: K160399 – Skyn Original Polyisoprene Male Condom Reason for 510(k) Submission: The subject device is a modified version of predicate dev… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | 2018 | 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K182438 (Sxwell USA, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160399.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Skyn Original Polyisoprene Lubricated Male Condom - Flavored 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/K171172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171172: Skyn Original Polyisoprene Lubricated Male Condom - Flavored.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171172
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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