510(k) · Cleared
ClearedTwinlotus and Shields Natural Rubber Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dailian Latex Company, Ltd. · HIS Condom
Cleared on Oct 24, 2008 as substantially equivalent to K032227 (Ssl Americas, Inc., 2004) after a 157-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.
- Decided
- Oct 24, 2008
- Review
- 157 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952415 (1996). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 2 generations backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- 1 generation backK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- This deviceK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- Descendant · cites it directly · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · 2 generations on · 1 of its ownK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK111093 Billy Boy Male Latex CondomMapa GmbH · 2011
- Descendant · 3 generations on · 0 of its ownK153016 aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK141256 Okamoto Studded CondomOkamoto USA, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · cites it directly5descendants
- K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · 2 generations on1descendant
- K111093Billy Boy Male Latex CondomMapa GmbH · 2011 · 2 generations on1descendant
- K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016 · 3 generations on0descendants
- K141256Okamoto Studded CondomOkamoto USA, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −2 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| −1 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| 0 (this device) | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| +1 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +2 | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | 1 |
| +2 | K111093 | Billy Boy Male Latex Condom | Mapa GmbH | 2011 | — |
| +3 | K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products, Ltd. | 2016 | — |
| +3 | K141256 | Okamoto Studded Condom | Okamoto USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K032227 | Durex Flavored Latex CondomSummary page 2…ent The Dalian twinlotus and shield condoms are of the same materials, have undergone the same testing and are substantially equivalent to the Durex flavored condoms, K032227. -End of Section - 19 DEPARTMEN… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103119 | Billy Boy Male Latex Condom | 2011 | 5 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K103119 (Sheila Pickering PHD, 2011) has gone furthest, with 5 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. 2008, 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 Twinlotus or Shield condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081413: Twinlotus and Shields Natural Rubber 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/K081413
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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