510(k) · Cleared
ClearedMaxima, Trustex, Ria and Premium Condoms
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ls Rubber Sdn Bhd · HIS Condom
Cleared on Mar 12, 1999 after a 361-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Mar 12, 1999
- Review
- 361 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
- Descendant · cites it directly · 15 of its ownK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
- Descendant · 2 generations on · 7 of its ownK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- Descendant · 3 generations on · 6 of its ownK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- Descendant · 2 generations on · 6 of its ownK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
- Descendant · 4 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K020633Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002 · cites it directly15descendants
- K032227Durex Flavored Latex CondomSsl Americas, Inc. · 2004 · 2 generations on7descendants
- K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008 · 3 generations on6descendants
- K023175Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002 · 2 generations on6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980964 | Maxima, Trustex, Ria and Premium Condoms | Ls Rubber Sdn Bhd | 1999 | — |
| +1 | K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | 2002 | — |
| +2 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| +3 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| +2 | K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | 2002 | — |
| +4 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 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), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020633 | Natural and Colored Latex Condom with Flavors | 2002 | 15 |
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, K020633 (Ls Rubber Sdn Bhd, 2002) has gone furthest, with 15 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 | — |
What is it indicated for?
The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980964: Maxima, Trustex, Ria and Premium Condoms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980964
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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