510(k) · Cleared
ClearedDotted Condom, Male Natural Rubber Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innolatex Sdn. Bhd · HIS Condom
Cleared on Nov 9, 2001 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 9, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK012962 Dotted Condom, Male Natural Rubber Latex CondomInnolatex Sdn. Bhd · 2001
- Descendant · cites it directly · 3 of its ownK081886 Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal…Karex Industries Sdn. Bhd. · 2009
- Descendant · 2 generations on · 2 of its ownK122219 Theyfit Male CondomTheyfit · 2013
- Descendant · cites it directly · 1 of its ownK040185 Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 2004
- Descendant · 3 generations on · 0 of its ownK210208 Titan CondomsTitan Condoms, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK150072 TheyFit Male CondomTheyfit · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081886Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…Karex Industries Sdn. Bhd. · 2009 · cites it directly3descendants
- K122219Theyfit Male CondomTheyfit · 2013 · 2 generations on2descendants
- K040185Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 2004 · cites it directly1descendant
- K210208Titan CondomsTitan Condoms, LLC · 2022 · 3 generations on0descendants
- K150072TheyFit Male CondomTheyfit · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012962 | Dotted Condom, Male Natural Rubber Latex Condom | Innolatex Sdn. Bhd | 2001 | — |
| +1 | K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated… | Karex Industries Sdn. Bhd. | 2009 | — |
| +2 | K122219 | Theyfit Male Condom | Theyfit | 2013 | — |
| +1 | K040185 | Durex Studded/Ribbed Lubricated Latex Condom | Ssl Americas | 2004 | — |
| +3 | K210208 | Titan Condoms | Titan Condoms, LLC | 2022 | — |
| +3 | K150072 | TheyFit Male Condom | Theyfit | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K081886 (Karex Industries Sdn. Bhd., 2009) has gone furthest, with 3 descendants of its own.
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 [No particular brand name] condom is used for contraception 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012962 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012962: Dotted Condom, Male Natural Rubber Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012962
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026