510(k) · Cleared

Cleared

Sagami Original 002 Polyurethane Male Condom

K252158510(k) TraditionalCleared Mar 30, 2026264-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mayer Laboratories · MOL Condom, Synthetic

Cleared on Mar 30, 2026 as substantially equivalent to K203541 (Okamoto USA, Inc., 2022) after a 264-day review. Its family tree reaches back 2 generations to 2011.

Decided: Mar 30, 2026
Review: 264 days
Class: Class II
Product code: MOL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K100767 (2011). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK100767 Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. · 2011
1 generation backK203541 Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc. · 2022
This deviceK252158 Sagami Original 002 Polyurethane Male CondomMayer Laboratories · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K100767	Trojan Supra Lubricated Polyurethane Male Condom	Church & Dwight Co., Inc.	2011	—
−1	K203541	Okamoto 002 Lubricated Polyurethane Male Condom	Okamoto USA, Inc.	2022	—
0 (this device)	K252158	Sagami Original 002 Polyurethane Male Condom	Mayer Laboratories	2026	—

FIG. 1 — Lineage of K252158, 2011–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K240379 TROJAN SIS Synthetic Latex Condom with…score 8.4 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K203541	Okamoto 002 Lubricated Polyurethane Male Condom Summary page 5 …ass II 5. Predicate Device Information Device Name: Okamoto 002 Lubricated Polyurethane Male Condom 510(k) Number: K203541 Sponsor: Okamoto U.S.A Inc. The predicate device has not been subject to a design-related recall…	Okamoto USA, Inc.	2022	—

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 15 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All MOL devices

MOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · MOL

2in 2025

2007high 3 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOL

244in 2024

2007high 244 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOL

3in 2018

2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOL

4in 2025

2007high 11 (2018) · low 0 (2007)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?

Sagami Original 002 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/K252158 · printed Nov 6, 2026

Cite this page

510(k) Report. “K252158: Sagami Original 002 Polyurethane 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/K252158

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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