510(k) · Cleared
ClearedOkamoto Studded Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Okamoto USA, Inc. · HIS Condom
Cleared on Jul 23, 2014 as substantially equivalent to K111093 (Mapa GmbH, 2011) after a 70-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Jul 23, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K952415 (1996). 19 ancestors in all, the oldest K871304 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 5 generations backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- 4 generations backK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- 3 generations backK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- 2 generations backK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- 1 generation backK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
- This deviceK141256 Okamoto Studded CondomOkamoto USA, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −5 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| −4 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| −3 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| −2 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| −1 | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
| 0 (this device) | 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 |
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 13.3 · 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? (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 |
|---|---|---|---|
| * | K111093 | Billy Boy Male Latex CondomSummary page 1…0) Predicate Device: 1) Brand Name: BillyBoy Dotted (Beaded) condom Company Name: MAPA GmbH 5 10(k) Document Control Number: K1 11093 Description of the Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a close… | 2011 |
| † | K893039 | Condom (Rubber) Contraceptive | 1990 |
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 18 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 19 ancestors has a recall.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Okamoto Studded Condom is used for contraceptive and 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/K141256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141256: Okamoto Studded Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141256
Report an extraction error
Are you the manufacturer?
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