510(k) · Cleared
ClearedOkamoto 002 Lubricated Polyurethane Male Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Okamoto USA, Inc. · MOL Condom, Synthetic
Cleared on Feb 25, 2022 as substantially equivalent to K100767 (Church & Dwight Co., Inc., 2011) after a 449-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.
- Decided
- Feb 25, 2022
- Review
- 449 days
- Class
- Class II
- Product code
- MOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100767 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK100767 Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. · 2011
- This deviceK203541 Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252158 Sagami Original 002 Polyurethane Male CondomMayer Laboratories · 2026
Most influential descendants
Showing 1 of 1 · See all- K252158Sagami Original 002 Polyurethane Male CondomMayer Laboratories · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100767 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2011 | — |
| 0 (this device) | K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto USA, Inc. | 2022 | — |
| +1 | K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K100767 | Trojan Supra Lubricated Polyurethane Male CondomSummary page 4…lass II 5. Predicate Device Information Device Name: Trojan Supra Lubricated Polyurethane Male Condom 510(k) Number: K100767 Sponsor: Church & Dwight Co, Inc. The predicate device has not been subject to a design-related r… | 2011 |
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 |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | 2026 | 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?
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Okamoto 002 Lubricated Polyurethane 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/K203541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203541: Okamoto 002 Lubricated Polyurethane 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/K203541
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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