510(k) Report

510(k) · Cleared

Cleared

Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated

K081886510(k) AbbreviatedCleared Feb 6, 2009219-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

Karex Industries Sdn. Bhd. · HIS Condom

Cleared on Feb 6, 2009 as substantially equivalent to K012962 (Innolatex Sdn. Bhd, 2001) and 4 other predicates after a 219-day review. Its family tree reaches back 5 generations to 1999. 3 later devices descend from it.

Decided
Feb 6, 2009
Review
219 days
Class
Class II
Product code
HIS
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K980964 (1999). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2001: 3 other ancestors2000: 1 other ancestor2013: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant clearedK980964 · Maxima, Trustex, Ria and Premium Condoms · Ls Rubber Sdn Bhd · 1999K020633 · Natural and Colored Latex Condom with Flavors · Ls Rubber Sdn Bhd · 2002K023175 · Unidus Male Latex Condom (with Color and Flavoring) · Unidus Corp. · 2002K041837 · Innolatex Male Latex Condoms Colored and Scented · Innolatex Sdn. Bhd · 2004K070830 · Male Natural Rubber Latex Condom (with Coloring and Flavoring) · Karex Industries Sdn. Bhd. · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants K070830 · Male Natural Rubber Latex Condom (with Coloring and Flavoring) · Karex Industries Sdn. Bhd. · 2007K041837 · Innolatex Male Latex Condoms Colored and Scented · Innolatex Sdn. Bhd · 2004K023175 · Unidus Male Latex Condom (with Color and Flavoring) · Unidus Corp. · 2002K020633 · Natural and Colored Latex Condom with Flavors · Ls Rubber Sdn Bhd · 2002K980964 · Maxima, Trustex, Ria and Premium Condoms · Ls Rubber Sdn Bhd · 1999−50
  1. Root · 5 generations backK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
  2. 4 generations backK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
  3. 3 generations backK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
  4. 2 generations backK041837 Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004
  5. 1 generation backK070830 Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007
  6. This deviceK081886 Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal…Karex Industries Sdn. Bhd. · 2009
  7. Descendant · cites it directly · 2 of its ownK122219 Theyfit Male CondomTheyfit · 2013
  8. Descendant · 2 generations on · 0 of its ownK210208 Titan CondomsTitan Condoms, LLC · 2022
  9. Descendant · 2 generations on · 0 of its ownK150072 TheyFit Male CondomTheyfit · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K122219Theyfit Male CondomTheyfit · 2013 · cites it directly2descendants
  • K210208Titan CondomsTitan Condoms, LLC · 2022 · 2 generations on0descendants
  • K150072TheyFit Male CondomTheyfit · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K980964Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd1999—
−4K020633Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd2002—
−3K023175Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp.2002—
−2K041837Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd2004—
−1K070830Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd.2007—
0 (this device)K081886Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated…Karex Industries Sdn. Bhd.2009—
+1K122219Theyfit Male CondomTheyfit2013—
+2K210208Titan CondomsTitan Condoms, LLC2022—
+2K150072TheyFit Male CondomTheyfit2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200130
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
202210
FIG. 1 — Lineage of K081886, 1999–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 13.3 · 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? (5)

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
*K012962Dotted Condom, Male Natural Rubber Latex Condom
Summary page 1
…: N/A. Common Name: Male Latex Condom v Classification Name : Male latex Condoin Predicate Devicees : Latex Lubricated Condom Innolatex Sdn. Bhd. : 510(k) Number = K012962 (Dotted Condorms) 510(k) Number = K010919 (Ribbed Condoms) 510(k) Number = K053367 (Non Lubricated Condoms) Karex Industries Sdn…
Innolatex Sdn. Bhd2001—
*K010919Male Natural Rubber Latex Condom
Summary page 1
…Classification Name : Male latex Condoin Predicate Devicees : Latex Lubricated Condom Innolatex Sdn. Bhd. : 510(k) Number = K012962 (Dotted Condorms) 510(k) Number = K010919 (Ribbed Condoms) 510(k) Number = K053367 (Non Lubricated Condoms) Karex Industries Sdn. Bhd. 510(k) Number=K070830 {Colored and…
Innolatex Sdn. Bhd2001—
*K053367Male Natural Rubber Latex Condom
Summary page 1
…in Predicate Devicees : Latex Lubricated Condom Innolatex Sdn. Bhd. : 510(k) Number = K012962 (Dotted Condorms) 510(k) Number = K010919 (Ribbed Condoms) 510(k) Number = K053367 (Non Lubricated Condoms) Karex Industries Sdn. Bhd. 510(k) Number=K070830 {Colored and Flavored Condoimns) Dongkuk Techeo Rubbe…
Innolatex Sdn. Bhd2006—
*K070830Male Natural Rubber Latex Condom (with Coloring and Flavoring)
Summary page 1
…k) Number = K012962 (Dotted Condorms) 510(k) Number = K010919 (Ribbed Condoms) 510(k) Number = K053367 (Non Lubricated Condoms) Karex Industries Sdn. Bhd. 510(k) Number=K070830 {Colored and Flavored Condoimns) Dongkuk Techeo Rubber Industries 510(k) Number = K002060 {Ribbed, Dotted & Contoured) === Page…
Karex Industries Sdn. Bhd.2007—
*K002060Natural Ordinary Ribbed,Dotted,and Contoured (Male Rubber Latex Condom, Lubricated…
Summary page 1
…r = K053367 (Non Lubricated Condoms) Karex Industries Sdn. Bhd. 510(k) Number=K070830 {Colored and Flavored Condoimns) Dongkuk Techeo Rubber Industries 510(k) Number = K002060 {Ribbed, Dotted & Contoured) Abbreviated 510(k) Notification for a Male Latex Condom·…
Dongkuk Techco Rubber Industries2000—

Also cleared against K012962: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122219Theyfit Male CondomTheyfit20132

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 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K122219 (Theyfit, 2013) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K012962.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 Karex condom is used for contraceptive and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K012962

1 other device cites the same predicate.

  • K040185Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 2004

More from Karex Industries Sdn. Bhd.

8 FDA decisions under this applicant name. See the company

  • K223519Carex Hybrid Personal LubricantKarex Industries Sdn. Bhd. · 2023
  • K150743Water Based Personal Lubricant with FlavoursKarex Industries Sdn. Bhd. · 2015
  • K141059Natural Rubber Latex Male CondomsKarex Industries Sdn. Bhd. · 2014
  • K132597Black Coloured CondomKarex Industries Sdn. Bhd. · 2013
  • K113056Orange Colored Condoms Orange ScentKarex Industries Sdn. Bhd. · 2012

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/K081886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081886: Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081886

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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