510(k) · Cleared

Cleared

Trojan-Enz Brand

K071313510(k) AbbreviatedCleared Oct 26, 2007169-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 Oct 26, 2007 as substantially equivalent to K897129 (Sagami, Inc., 1990) after a 169-day review. Its family tree reaches back 1 generation to 1990. 13 later devices descend from it.

Decided: Oct 26, 2007
Review: 169 days
Class: Class II
Product code: HIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K897129 (1990). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK897129 Condoms (Multiple Brands)Sagami, Inc. · 1990
This deviceK071313 Trojan-Enz BrandChurch & Dwight Co., Inc. · 2007
Descendant · cites it directly · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
Descendant · cites it directly · 5 of its ownK083817 M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009
Descendant · 2 generations on · 3 of its ownK162919 Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. · 2017
Descendant · 3 generations on · 2 of its ownK220576 FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. · 2022
Descendant · 2 generations on · 1 of its ownK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009high 2 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 13 · See all

K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · cites it directly5descendants
K083817M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009 · cites it directly5descendants
K162919Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. · 2017 · 2 generations on3descendants
K220576FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. · 2022 · 3 generations on2descendants
K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K897129	Condoms (Multiple Brands)	Sagami, Inc.	1990	—
0 (this device)	K071313	Trojan-Enz Brand	Church & Dwight Co., Inc.	2007	—
+1	K103119	Billy Boy Male Latex Condom	Sheila Pickering PHD	2011	—
+1	K083817	M. Dior Brand	Suzhou Colour-Way Enterprise Development Co., Ltd.	2009	—
+2	K162919	Male Latex Condoms	Zhejiang Xiangban Latex Products Co., Ltd.	2017	—
+3	K220576	FAMA Male Latex Condoms	Shanghai Personage Hygiene Products Co., Ltd.	2022	—
+2	K120394	Lifestyles Zero Lubricated Latex Condom	Ansell Heathcare Products, LLC	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	2	0
2012	2	0
2014	1	0
2015	1	0
2016	2	0
2017	1	0
2022	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K071313, 1990–2026Source: 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 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K897129	Condoms (Multiple Brands) Summary page 1 …and Multiple Brands Sagami Rubber Industries Co., Ltd K897129 Description of the Device: The condoms are made of a natural rubber latex sheath, which co…	Sagami, Inc.	1990	—
*	—	TROJAN-ENZ® Male Latex Condoms Named without a submission number			—

Also cleared against K897129: 1 other device →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103119	Billy Boy Male Latex Condom	Sheila Pickering PHD	2011	5
K083817	M. Dior Brand	Suzhou Colour-Way Enterprise Development Co., Ltd.	2009	5
K161195	Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)	M3 Global Enterprises, LLC	2016	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, K103119 (Sheila Pickering PHD, 2011) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K897129.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

The TROJAN-ENZ® brand condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071313 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071313: Trojan-Enz Brand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071313

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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