510(k) · Cleared
ClearedTitan Condoms
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Condoms, LLC · HIS Condom
Cleared on Feb 17, 2022 as substantially equivalent to K122219 (Theyfit, 2013) after a 387-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Feb 17, 2022
- Review
- 387 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K980964 (1999). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
- 6 generations backK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
- 5 generations backK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
- 4 generations backK041837 Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004
- 3 generations backK070830 Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007
- 2 generations backK081886 Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal…Karex Industries Sdn. Bhd. · 2009
- 1 generation backK122219 Theyfit Male CondomTheyfit · 2013
- This deviceK210208 Titan CondomsTitan Condoms, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K980964 | Maxima, Trustex, Ria and Premium Condoms | Ls Rubber Sdn Bhd | 1999 | — |
| −6 | K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | 2002 | — |
| −5 | K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | 2002 | — |
| −4 | K041837 | Innolatex Male Latex Condoms Colored and Scented | Innolatex Sdn. Bhd | 2004 | — |
| −3 | 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 | — |
| −1 | K122219 | Theyfit Male Condom | Theyfit | 2013 | — |
| 0 (this device) | K210208 | Titan Condoms | Titan Condoms, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K122219 | Theyfit Male CondomSummary page 4…bber Latex Condom Regulation Name: Condom Regulation 21 CFR 884.5300 Number: Product Code: HIS (Condom) Regulatory Class: II Predicate Device: K122219 – TheyFit Male Condom The predicate device has not been subject to a design-related recall.… | 2013 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K122219.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210208: Titan Condoms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210208
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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