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
Cleared on Jun 3, 2011 as substantially equivalent to K103119 (Sheila Pickering PHD, 2011) and 2 other predicates after a 45-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jun 3, 2011
- Review
- 45 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K952415 (1996). 18 ancestors in all, the oldest K871304 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 4 generations backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- 3 generations backK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- 2 generations backK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- 1 generation backK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- This deviceK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
- Descendant · cites it directly · 0 of its ownK141256 Okamoto Studded CondomOkamoto USA, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141256Okamoto Studded CondomOkamoto USA, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −4 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| −3 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| −2 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| −1 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| 0 (this device) | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
| +1 | K141256 | Okamoto Studded Condom | Okamoto USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 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 |
|---|---|---|
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K103119 | Billy Boy Male Latex CondomSummary page 1…4.5300) Predicate Devices: Device Mfg K# Billy Boy MAPA K103119 condoms GmbH SLAM Condom Nippon K0l11253… | 2011 |
| * | K011253 | Flavored Male Latex CondomSummary page 4…fac Comparison of Modified Device with SLAM Predicate Device (K011253) SLAM Condom Billy Boy with Dotted! Manufact… | 2001 |
| * | K871304 | Lifestyles Extra Strength Condoms W/Nonoxynol-9Summary page 1…manufactured by; Rubber Industry Lifestyles Extra Ansell K871304 Strength) Ultra Inc. Thick Male Latex… | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141256 | Okamoto Studded Condom | 2014 | 0 |
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 6 companies; a new generation was cleared every 2.3 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K141256 (Okamoto USA, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103119.
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 BillyBoy male latex condom is used for contraceptive
and for prophylactic purposes (to help prevent pregnancy and the transmission of
sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New
Condom models.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111093: 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/K111093
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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