510(k) · Cleared
ClearedBilly Boy Male Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheila Pickering PHD · HIS Condom
Cleared on Feb 24, 2011 as substantially equivalent to K081413 (Dailian Latex Company, Ltd., 2008) and 6 other predicates after a 125-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 24, 2011
- Review
- 125 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K952415 (1996). 16 ancestors in all, the oldest K890863 (1989). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 3 generations backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- 2 generations backK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- 1 generation backK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- This deviceK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · cites it directly · 1 of its ownK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
- Descendant · 2 generations on · 0 of its ownK153016 aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK141256 Okamoto Studded CondomOkamoto USA, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK120287 Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · cites it directly1descendant
- K111093Billy Boy Male Latex CondomMapa GmbH · 2011 · cites it directly1descendant
- K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016 · 2 generations on0descendants
- K141256Okamoto Studded CondomOkamoto USA, Inc. · 2014 · 2 generations on0descendants
- K120287Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −3 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| −2 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| −1 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| 0 (this device) | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +1 | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | 1 |
| +1 | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
| +2 | K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products, Ltd. | 2016 | — |
| +2 | K141256 | Okamoto Studded Condom | Okamoto USA, Inc. | 2014 | — |
| +1 | K120287 | Trojan Magnum Condom with Fire & Ice Lubricant | Church & Dwight Co., Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (7)
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 |
|---|---|---|---|
| * | K081413 | Twinlotus and Shields Natural Rubber Latex CondomSummary page 1…Manufacturer Device Name Applicable SE 510(k) # ___ Dalian Latex Twin Lotus Male K081413 Yes Company Ltd. Latex Condoms Mayer* Kimono Manx K943064, Yes Laboratories… | 2008 |
| * | K943064 | Kimono (Condoms)Summary page 1…510(k) # ___ Dalian Latex Twin Lotus Male K081413 Yes Company Ltd. Latex Condoms Mayer* Kimono Manx K943064, Yes Laboratories K904375 Church & Dwight Trojan Her K0730 16, Yes… | 1995 |
| * | K904375 | Kimono PlusSummary page 1…Male K081413 Yes Company Ltd. Latex Condoms Mayer* Kimono Manx K943064, Yes Laboratories K904375 Church & Dwight Trojan Her K0730 16, Yes co., Inc. and Pleasure K(071313, Armkel, 1… | 1990 |
| * | K073016 | Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm…Summary page 1…Latex Condoms Mayer* Kimono Manx K943064, Yes Laboratories K904375 Church & Dwight Trojan Her K0730 16, Yes co., Inc. and Pleasure K(071313, Armkel, 11c. K(071272,… | 2007 |
| * | K071313 | Trojan-Enz BrandSummary page 1…, Yes Laboratories K904375 Church & Dwight Trojan Her K0730 16, Yes co., Inc. and Pleasure K(071313, Armkel, 11c. K(071272, K023405 Description of the Dev… | 2007 |
| * | K071272 | Trojan Thintensity Brand Male Latex CondomSummary page 1…K904375 Church & Dwight Trojan Her K0730 16, Yes co., Inc. and Pleasure K(071313, Armkel, 11c. K(071272, K023405 Description of the Device: The BillyBoy condom is made of a natural rubber… | 2007 |
| * | K023405 | Trojan Mint Tingle Brand Latex CondomsSummary page 1…K0730 16, Yes co., Inc. and Pleasure K(071313, Armkel, 11c. K(071272, K023405 Description of the Device: The BillyBoy condom is made of a natural rubber latex sheath, which completely covers the penis with… | 2002 |
What descends from it? (5)
3 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 15 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K120394 (Ansell Heathcare Products, LLC, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103119: Billy Boy Male Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103119
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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