510(k) · Cleared
ClearedSynthetic Polyisoprene Lubricated Male Condom - 5 senses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sxwell USA, LLC · MOL Condom, Synthetic
Cleared on Dec 6, 2018 as substantially equivalent to K171172 (Ansell Healthcare Products, LLC, 2017) after a 90-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 6, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941258 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK941258 Latex CondomSuretex, Ltd. · 1995 · Recalled
- 3 generations backK070800 Lifestyles Lubricated Polyisoprene Latex Male CondomAnsell Healthcare Products, LLC · 2008
- 2 generations backK160399 Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016 · Recalled
- 1 generation backK171172 Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC · 2017
- This deviceK182438 Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941258 | Latex Condom | Suretex, Ltd. | 1995 | 1 |
| −3 | 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 |
| −1 | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017 | — |
| 0 (this device) | K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | 2018 | — |
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 |
|---|---|---|---|
| * | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredSummary page 4…Condom Classification Regulation: 21 CFR 884.5300 Device Class: Class II Product Code: MOL (Condom, Synthetic) Predicate Device: K171172 – Synthetic Polyisoprene Male Condom ‐ Flavored The predicate device has not been subject to a design-related recall. Device De… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Synthetic Polyisoprene Lubricated Male Condom - 5 Senses 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 as stated in the FDA summary.
https://510kreport.com/device/K182438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182438: Synthetic Polyisoprene Lubricated Male Condom - 5 senses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182438
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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