510(k) · Cleared
ClearedFlavored Male Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thai Nippon Rubber Industry Co., Ltd. · HIS Condom
Cleared on Jul 20, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jul 20, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK011253 Flavored Male Latex CondomThai Nippon Rubber Industry Co., Ltd. · 2001
- Descendant · cites it directly · 7 of its ownK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- Descendant · 3 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K032227Durex Flavored Latex CondomSsl Americas, Inc. · 2004 · cites it directly7descendants
- K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008 · 2 generations on6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 3 generations on5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011253 | Flavored Male Latex Condom | Thai Nippon Rubber Industry Co., Ltd. | 2001 | — |
| +1 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| +2 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| +3 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 13.3 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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, K032227 (Ssl Americas, Inc., 2004) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K011253 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011253: Flavored Male 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/K011253
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026