510(k) Report

510(k) · Cleared

Cleared

Divas Dual Pleasure Male Latex Condom

K051273510(k) AbbreviatedCleared Aug 19, 200594-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

Eagle Twe, Inc. · HIS Condom

Cleared on Aug 19, 2005 as substantially equivalent to K042957 (Ssl Americas, 2005) and 3 other predicates after a 94-day review. Its family tree reaches back 2 generations to 1992.

Decided
Aug 19, 2005
Review
94 days
Class
Class II
Product code
HIS
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K912901 (1992). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestorK912901 · Trojan (TM-TBD) Condom · Carter Products · 1992K984488 · Sheer Thin · Twe Companies, Inc. · 19991990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K984488 · Sheer Thin · Twe Companies, Inc. · 1999K912901 · Trojan (TM-TBD) Condom · Carter Products · 19920
  1. Root · 2 generations backK912901 Trojan (TM-TBD) CondomCarter Products · 1992
  2. 1 generation backK984488 Sheer ThinTwe Companies, Inc. · 1999
  3. This deviceK051273 Divas Dual Pleasure Male Latex CondomEagle Twe, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K912901Trojan (TM-TBD) CondomCarter Products1992—
−1K984488Sheer ThinTwe Companies, Inc.1999—
0 (this device)K051273Divas Dual Pleasure Male Latex CondomEagle Twe, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200510
FIG. 1 — Lineage of K051273, 1992–2005Source: 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? (4)

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
*K042957Durex Male Latex Condom with Warming Lubricant
Summary page 1
…n Name: Condom Classification Name: Condom (Rubber) Contraceptive Predicate Device: Durex Warming Pleasure Latex Condom 510K # K042957 KY Warming liquid personal lubricant 510K # K021492 Inv…
Ssl Americas2005—
*K021492K-Y Brand Warming Liquid Personal Lubricant
Summary page 1
…Durex Warming Pleasure Latex Condom 510K # K042957 KY Warming liquid personal lubricant 510K # K021492 Invigra Male Latex Condom 510K# K991374 Sheer Thin Natu…
Personal Products Co., Div. of Mcneil Ppc, Inc.2002—
*K991374Invigra
Summary page 1
…KY Warming liquid personal lubricant 510K # K021492 Invigra Male Latex Condom 510K# K991374 Sheer Thin Natural Rubber Latex Condom 510K # K984488 Description of the Devic…
Indus Medicare, Ltd.1999—
*K984488Sheer Thin
Summary page 1
…Invigra Male Latex Condom 510K# K991374 Sheer Thin Natural Rubber Latex Condom 510K # K984488 Description of the Device: This condom is made of a natural rubber latex sheath, which…
Twe Companies, Inc.1999—

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?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
  • None of the 6 ancestors has a recall.

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?

The Divas Dual Pleasure 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.

More from Eagle Twe, Inc.

5 FDA decisions under this applicant name. See the company

  • K010028Sheer Thin Aromas Red Latex CondomEagle Twe, Inc. · 2001
  • K004051Sheer Thin Aromas Yellow Latex CondomEagle Twe, Inc. · 2001
  • K004016Sheer Thin Aromas Blue Latex CondomEagle Twe, Inc. · 2001
  • K004036Sheer Thin Aromas Green Latex CondomEagle Twe, Inc. · 2001

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/K051273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051273: Divas Dual Pleasure Male Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051273

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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