510(k) · Cleared

Cleared

Mega Big Boy Condom

K140379510(k) AbbreviatedCleared Jul 1, 2014137-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 Jul 1, 2014 as substantially equivalent to K001212 (Armkel, LLC, 2000) after a 137-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Jul 1, 2014
Review: 137 days
Class: Class II
Product code: HIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001212 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001212 Trojan Extra Large Latex CondomArmkel, LLC · 2000
This deviceK140379 Mega Big Boy CondomOkamoto USA, Inc. · 2014
Descendant · cites it directly · 0 of its ownK243584 0.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K140379, 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 13.2 · 5 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
*	K001212	Trojan Extra Large Latex Condom Summary page 1 …Predicate Device: Brand Name: TROJAN EXTRA LARGE LATEX CODOM Company Name: Church & Dwight Co., Ltd. 510(k) Document Control Number: K001212 Description of the Device: This condom is made of a natural rubber latex sheath, which completely covers the peni…	Armkel, LLC	2000	—

Also cleared against K001212: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K243584	0.04 ZERO ZERO FOUR Male Latex Condom	Okamoto USA, Inc.	2025	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?

Its one ancestor has no recall.
Of its descendants, K243584 (Okamoto USA, Inc., 2025) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K001212.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/AIDS and the transmission of sexually transmitted infections).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140379 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140379: Mega Big Boy Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140379

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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