510(k) · Cleared

Cleared

Durex Male Colored Latex Condoms with Scented Lubricants

K052959510(k) AbbreviatedCleared Jan 27, 200698-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 Jan 27, 2006 as substantially equivalent to K980174 (London Intl., LLC, 1998) and 1 other predicate after a 98-day review. Its family tree reaches back 1 generation to 1990.

Decided: Jan 27, 2006
Review: 98 days
Class: Class II
Product code: HIS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K900679 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK900679 Mint Scented CondomsSchmid Laboratories, Inc. · 1990
This deviceK052959 Durex Male Colored Latex Condoms with Scented LubricantsSsl Americas · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900679	Mint Scented Condoms	Schmid Laboratories, Inc.	1990	—
0 (this device)	K052959	Durex Male Colored Latex Condoms with Scented Lubricants	Ssl Americas	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K052959, 1990–2006Source: 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? (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
*	K980174	Durex Colors and Scents Summary page 1 …scented lubricants Trade name: Durex Tropical E. Common Name Male latex condom F. Classification Name HIS G. Predicate Devices Durex Colors and Scents - 510(k) Number K980174 Durex Mint Scented Condom - 510(k) Number K900679 (plus 'note to file' line extension dated 30.09.2003) H. Description of the De…	London Intl., LLC	1998	—
*	K900679	Mint Scented Condoms Summary page 1 …Common Name Male latex condom F. Classification Name HIS G. Predicate Devices Durex Colors and Scents - 510(k) Number K980174 Durex Mint Scented Condom - 510(k) Number K900679 (plus 'note to file' line extension dated 30.09.2003) H. Description of the Device The condom is made of a natural rubber latex…	Schmid Laboratories, Inc.	1990	—

Also cleared against K980174: 1 other device →

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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K980174.

How does its category compare?

All HIS devices

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

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?

Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052959 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052959: Durex Male Colored Latex Condoms with Scented Lubricants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052959

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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