510(k) · Cleared
ClearedUnidus Male Latex Condom (with Color and Flavoring)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unidus Corp. · HIS Condom
Cleared on Dec 13, 2002 as substantially equivalent to K020633 (Ls Rubber Sdn Bhd, 2002) after an 81-day review. Its family tree reaches back 2 generations to 1999. 6 later devices descend from it.
- Decided
- Dec 13, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980964 (1999). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
- 1 generation backK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
- This deviceK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
- Descendant · cites it directly · 5 of its ownK041837 Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004
- Descendant · 2 generations on · 4 of its ownK070830 Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007
- Descendant · 3 generations on · 3 of its ownK081886 Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal…Karex Industries Sdn. Bhd. · 2009
- Descendant · 4 generations on · 2 of its ownK122219 Theyfit Male CondomTheyfit · 2013
- Descendant · 5 generations on · 0 of its ownK210208 Titan CondomsTitan Condoms, LLC · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041837Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004 · cites it directly5descendants
- K070830Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007 · 2 generations on4descendants
- K081886Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…Karex Industries Sdn. Bhd. · 2009 · 3 generations on3descendants
- K122219Theyfit Male CondomTheyfit · 2013 · 4 generations on2descendants
- K210208Titan CondomsTitan Condoms, LLC · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980964 | Maxima, Trustex, Ria and Premium Condoms | Ls Rubber Sdn Bhd | 1999 | — |
| −1 | K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | 2002 | — |
| 0 (this device) | K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | 2002 | — |
| +1 | K041837 | Innolatex Male Latex Condoms Colored and Scented | Innolatex Sdn. Bhd | 2004 | — |
| +2 | K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring) | Karex Industries Sdn. Bhd. | 2007 | — |
| +3 | K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated… | Karex Industries Sdn. Bhd. | 2009 | — |
| +4 | K122219 | Theyfit Male Condom | Theyfit | 2013 | — |
| +5 | K210208 | Titan Condoms | Titan Condoms, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K020633 | Natural and Colored Latex Condom with Flavors | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041837 | Innolatex Male Latex Condoms Colored and Scented | 2004 | 5 |
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 3 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041837 (Innolatex Sdn. Bhd, 2004) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K020633.
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 UNIDUS 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/K023175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023175: Unidus Male Latex Condom (with Color and Flavoring).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023175
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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