510(k) · Cleared

Cleared

Durex, Ramses, Sheik

K952415510(k) TraditionalCleared Jul 15, 1996419-day reviewClass II21 CFR 884.5310

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

London International U.S. Holdings, Inc. · LTZ Condom With Nonoxynol-9

Cleared on Jul 15, 1996 after a 419-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.

Decided: Jul 15, 1996
Review: 419 days
Class: Class II
Product code: LTZ
Recalls: None
Predicates: 0

13 later devices descend from it, 3 citing it directly.

This deviceK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
Descendant · cites it directly · 8 of its ownK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
Descendant · 2 generations on · 7 of its ownK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
Descendant · 3 generations on · 6 of its ownK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
Descendant · 4 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
Descendant · cites it directly · 2 of its ownK020659 Durex Latex Condom with Male Genital Desensitizer LubricantSsl Americas, Inc. · 2002

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1998high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 13 · See all

K983380Durex Lubragel Latex CondomLondon Intl., LLC · 1998 · cites it directly8descendants
K032227Durex Flavored Latex CondomSsl Americas, Inc. · 2004 · 2 generations on7descendants
K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008 · 3 generations on6descendants
K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 4 generations on5descendants
K020659Durex Latex Condom with Male Genital Desensitizer LubricantSsl Americas, Inc. · 2002 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952415	Durex, Ramses, Sheik	London International U.S. Holdings, Inc.	1996	—
+1	K983380	Durex Lubragel Latex Condom	London Intl., LLC	1998	—
+2	K032227	Durex Flavored Latex Condom	Ssl Americas, Inc.	2004	—
+3	K081413	Twinlotus and Shields Natural Rubber Latex Condom	Dailian Latex Company, Ltd.	2008	—
+4	K103119	Billy Boy Male Latex Condom	Sheila Pickering PHD	2011	—
+1	K020659	Durex Latex Condom with Male Genital Desensitizer Lubricant	Ssl Americas, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2002	1	0
2004	1	0
2008	1	0
2011	2	0
2012	2	0
2014	1	0
2016	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K952415, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
K983380	Durex Lubragel Latex Condom	London Intl., LLC	1998	8
K020659	Durex Latex Condom with Male Genital Desensitizer Lubricant	Ssl Americas, Inc.	2002	2
K982924	Durex Sensidom Latex Condom	London Intl., LLC	1998	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?

Of its descendants, K983380 (London Intl., LLC, 1998) has gone furthest, with 8 descendants of its own.

How does its category compare?

All LTZ devices

LTZ Condom With Nonoxynol-9: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTZ

FDA has decided no LTZ device since 2007.

Median 510(k) review, days · LTZ

Too few LTZ 510(k)s in any year since 2007 to give a median.

Recalls per year · LTZ

No recall names LTZ since 2007.

Adverse event reports per year · LTZ

1in 2014

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code LTZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	1
2013	—	0
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K952415 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952415: Durex, Ramses, Sheik.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952415

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026