510(k) · Cleared

Cleared

0.04 ZERO ZERO FOUR Male Latex Condom

K243584510(k) AbbreviatedCleared Feb 18, 202590-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

Cleared on Feb 18, 2025 as substantially equivalent to K140379 (Okamoto USA, Inc., 2014) after a 90-day review. Its family tree reaches back 2 generations to 2000.

Decided: Feb 18, 2025
Review: 90 days
Class: Class II
Product code: HIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K001212 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK001212 Trojan Extra Large Latex CondomArmkel, LLC · 2000
1 generation backK140379 Mega Big Boy CondomOkamoto USA, Inc. · 2014
This deviceK243584 0.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001212	Trojan Extra Large Latex Condom	Armkel, LLC	2000	—
−1	K140379	Mega Big Boy Condom	Okamoto USA, Inc.	2014	—
0 (this device)	K243584	0.04 ZERO ZERO FOUR Male Latex Condom	Okamoto USA, Inc.	2025	—

FIG. 1 — Lineage of K243584, 2000–2025Source: 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 HIS? 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 HIS device

#1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K140379	Mega Big Boy Condom Summary page 5 …gulation Name: Condom Regulation Number: 21 CFR 884.5300 Product Code: HIS (condom) Regulatory Class: Class II Predicate Device: K140379: Mega Big Boy Condom The predicate device has not been subject to a design related recall. Description…	Okamoto USA, Inc.	2014	—

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 25 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · HIS

5in 2025

2007high 10 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIS

99in 2025

2007high 242 (2014) · low 54 (2011)2026

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

Recalls per year · HIS

1in 2013

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · HIS

20in 2025

2007high 22 (2010) · low 5 (2016)2025

MAUDE reports naming product code HIS, 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	7	128	1	10
2008	3	157	0	11
2009	5	241	0	12
2010	1	—	0	22
2011	3	54	0	15
2012	7	106	1	10
2013	4	208	1	19
2014	7	242	0	16
2015	3	136	0	8
2016	5	115	0	5
2017	4	102	0	8
2018	2	—	0	11
2019	1	—	0	15
2020	4	240	0	12
2021	5	233	0	16
2022	10	112	0	18
2023	2	—	0	10
2024	0	—	0	7
2025	5	99	0	20
2026	2	—	0	—

What is it indicated for?

0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K243584 · printed Nov 5, 2026

Cite this page

510(k) Report. “K243584: 0.04 ZERO ZERO FOUR Male Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243584

Report an extraction error

Are you the manufacturer?

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