510(k) · Cleared
ClearedInnolatex Male Latex Condoms Colored and Scented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innolatex Sdn. Bhd · HIS Condom
Cleared on Sep 24, 2004 as substantially equivalent to K011253 (Thai Nippon Rubber Industry Co., Ltd., 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1999. 5 later devices descend from it.
- Decided
- Sep 24, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980964 (1999). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
- 2 generations backK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
- 1 generation backK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
- This deviceK041837 Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004
- Descendant · cites it directly · 4 of its ownK070830 Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007
- Descendant · 2 generations on · 3 of its ownK081886 Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal…Karex Industries Sdn. Bhd. · 2009
- Descendant · 3 generations on · 2 of its ownK122219 Theyfit Male CondomTheyfit · 2013
- Descendant · 4 generations on · 0 of its ownK210208 Titan CondomsTitan Condoms, LLC · 2022
- Descendant · 4 generations on · 0 of its ownK150072 TheyFit Male CondomTheyfit · 2015
Most influential descendants
Showing 5 of 5 · See all- K070830Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007 · cites it directly4descendants
- K081886Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…Karex Industries Sdn. Bhd. · 2009 · 2 generations on3descendants
- K122219Theyfit Male CondomTheyfit · 2013 · 3 generations on2descendants
- K210208Titan CondomsTitan Condoms, LLC · 2022 · 4 generations on0descendants
- K150072TheyFit Male CondomTheyfit · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980964 | Maxima, Trustex, Ria and Premium Condoms | Ls Rubber Sdn Bhd | 1999 | — |
| −2 | K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | 2002 | — |
| −1 | K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | 2002 | — |
| 0 (this device) | K041837 | Innolatex Male Latex Condoms Colored and Scented | Innolatex Sdn. Bhd | 2004 | — |
| +1 | K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring) | Karex Industries Sdn. Bhd. | 2007 | — |
| +2 | K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated… | Karex Industries Sdn. Bhd. | 2009 | — |
| +3 | K122219 | Theyfit Male Condom | Theyfit | 2013 | — |
| +4 | K210208 | Titan Condoms | Titan Condoms, LLC | 2022 | — |
| +4 | K150072 | TheyFit Male Condom | Theyfit | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K011253 | Flavored Male Latex CondomSummary page 1…Common Name: Male Latex Condom Classification Name: Male Latex Condom Predicate Devices: Thai Nippon Male Latex Condom: K011253 UNIDUS Male Latex Condom: K023175 Description of Device: This condom is made of a n… | 2001 |
| * | K023175 | Unidus Male Latex Condom (with Color and Flavoring)Summary page 1…cation Name: Male Latex Condom Predicate Devices: Thai Nippon Male Latex Condom: K011253 UNIDUS Male Latex Condom: K023175 Description of Device: This condom is made of a natural latex sheath, which completely… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring) | 2007 | 4 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070830 (Karex Industries Sdn. Bhd., 2007) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K011253.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 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?
The Innolatex condom is used for contraceptive and for
prophylactic purposes (to help prevent pregnancy and the
transmission of sexually transmitted diseases).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041837: Innolatex Male Latex Condoms Colored and Scented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041837
Report an extraction error
Are you the manufacturer?
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