510(k) Report

510(k) · Cleared

Cleared

Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' Condom

K042470510(k) AbbreviatedCleared Apr 5, 2005204-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

Ssl Americas, Inc. · HIS Condom

Cleared on Apr 5, 2005 as substantially equivalent to K980319 (London Intl., LLC, 1998) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 1990.

Decided
Apr 5, 2005
Review
204 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.

Other ancestors, by year cleared 1998: 1 other ancestorK900679 · Mint Scented Condoms · Schmid Laboratories, Inc. · 19901990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K900679 · Mint Scented Condoms · Schmid Laboratories, Inc. · 19900
  1. Root · 1 generation backK900679 Mint Scented CondomsSchmid Laboratories, Inc. · 1990
  2. This deviceK042470 Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling…Ssl Americas, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K900679Mint Scented CondomsSchmid Laboratories, Inc.1990—
0 (this device)K042470Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure'…Ssl Americas, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K042470, 1990–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K980319Durex Ultra Comfort
Summary page 1
…ame Durex 'Tingling Pleasure' E. Common Name Male Latex Condom F. Classification Name HIS G. Predicated Device Durex Ultra Comfort Latex Rubber Condom [510(k) Number K980319]. Spearmint scented green condom [510(k) Number K900679]. H. Description of the Device This condom is made of a natural rubber l…
London Intl., LLC1998—
*K900679Mint Scented Condoms
Summary page 1
…Condom F. Classification Name HIS G. Predicated Device Durex Ultra Comfort Latex Rubber Condom [510(k) Number K980319]. Spearmint scented green condom [510(k) Number K900679]. H. Description of the Device This condom is made of a natural rubber latex sheath, which completely covers the penis with a cl…
Schmid Laboratories, Inc.1990—

Also cleared against K980319: 4 other devices →

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.
  • 4 other devices also cite its predicate K980319.

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

2007: 72008: 32009: 52010: 12011: 32012: 72013: 42014: 72015: 32016: 52017: 42018: 22019: 12020: 42021: 52022: 102023: 22025: 52026 (partial year): 2
2007high 10 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIS

99in 2025

2007: 128 days median2008: 157 days median2009: 241 days median2011: 54 days median2012: 106 days median2013: 208 days median2014: 242 days median2015: 136 days median2016: 115 days median2017: 102 days median2020: 240 days median2021: 233 days median2022: 112 days median2025: 99 days median
2007high 242 (2014) · low 54 (2011)2026

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

Recalls per year · HIS

1in 2013

2007: 12012: 12013: 1
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

2007: 102008: 112009: 122010: 222011: 152012: 102013: 192014: 162015: 82016: 52017: 82018: 112019: 152020: 122021: 162022: 182023: 102024: 72025: 20
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077128110
20083157011
20095241012
20101—022
2011354015
20127106110
20134208119
20147242016
2015313608
2016511505
2017410208
20182—011
20191—015
20204240012
20215233016
202210112018
20232—010
20240—07
2025599020
20262—0—

What is it indicated for?

This Durex latex condom is 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.

Also cleared against K980319

4 other devices cite the same predicate.

  • K131866SustainHollender Sustainable Brands, LLC · 2014
  • K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 20084 recalls
  • K042957Durex Male Latex Condom with Warming LubricantSsl Americas · 2005
  • K040185Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 2004

More from Ssl Americas, Inc.

10 FDA decisions under this applicant name. See the company

  • K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 20084 recalls
  • K063385Durex Play Massage Gel LubricantSsl Americas, Inc. · 2008
  • K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
  • K042958Durex Play Tingling LubricantSsl Americas, Inc. · 2005
  • K042563Durex Play Warmer LubricantSsl Americas, Inc. · 2005

Recent decisions in HIS

The HIS category page

  • K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant…Shanghai Personage Hygiene Products Co., Ltd. · 2026
  • K252622Male Latex Condom HAOkamoto USA, Inc. · 2026
  • K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited · 2025
  • K250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd. · 2025
  • K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc. · 2025

https://510kreport.com/device/K042470 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042470: Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042470

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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