510(k) · Cleared
ClearedTheyfit Male Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Sep 27, 2013 as substantially equivalent to K113061 (Karex Industries Sdn. Bhd., 2011) and 1 other predicate after a 429-day review. Its family tree reaches back 6 generations to 1999. 2 later devices descend from it.
- Decided
- Sep 27, 2013
- Review
- 429 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K980964 (1999). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
- 5 generations backK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
- 4 generations backK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
- 3 generations backK041837 Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004
- 2 generations backK070830 Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd. · 2007
- 1 generation backK081886 Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal…Karex Industries Sdn. Bhd. · 2009
- This deviceK122219 Theyfit Male CondomTheyfit · 2013
- Descendant · cites it directly · 0 of its ownK210208 Titan CondomsTitan Condoms, LLC · 2022
- Descendant · cites it directly · 0 of its ownK150072 TheyFit Male CondomTheyfit · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K980964 | Maxima, Trustex, Ria and Premium Condoms | Ls Rubber Sdn Bhd | 1999 | — |
| −5 | K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | 2002 | — |
| −4 | K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | 2002 | — |
| −3 | 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 | — |
| −1 | K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated… | Karex Industries Sdn. Bhd. | 2009 | — |
| 0 (this device) | K122219 | Theyfit Male Condom | Theyfit | 2013 | — |
| +1 | K210208 | Titan Condoms | Titan Condoms, LLC | 2022 | — |
| +1 | K150072 | TheyFit Male Condom | Theyfit | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K113061 | Large/Extra Lagre CondomSummary page 1…Product Code: HIS PREDICATE DEVICE NAME: Karex Large and Extra Large Natural Rubber Latex Condoms, K1 13061 Karex Male Natural Rubber Latex Condom, K08 1886 DESCRIPTION OF THE DEVICE: The TheyFit M… | 2011 |
| * | K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…Summary page 1…nd Extra Large Natural Rubber Latex Condoms, K1 13061 Karex Male Natural Rubber Latex Condom, K08 1886 DESCRIPTION OF THE DEVICE: The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis… | 2009 |
What descends from it? (2)
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?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K210208 (Titan Condoms, LLC, 2022) has gone furthest, with 0 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. 2013, 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 TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122219: Theyfit Male Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122219
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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