510(k) · Cleared
ClearedNatural and Colored Latex Condom with Flavors
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 May 15, 2002 as substantially equivalent to K980964 (Ls Rubber Sdn Bhd, 1999) after a 77-day review. Its family tree reaches back 1 generation to 1999. 15 later devices descend from it.
- Decided
- May 15, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980964 (1999). 15 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980964 Maxima, Trustex, Ria and Premium CondomsLs Rubber Sdn Bhd · 1999
- This deviceK020633 Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd · 2002
- Descendant · cites it directly · 7 of its ownK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- Descendant · cites it directly · 6 of its ownK023175 Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002
- Descendant · 3 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · 2 generations on · 5 of its ownK041837 Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K032227Durex Flavored Latex CondomSsl Americas, Inc. · 2004 · cites it directly7descendants
- K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008 · 2 generations on6descendants
- K023175Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp. · 2002 · cites it directly6descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 3 generations on5descendants
- K041837Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd · 2004 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980964 | Maxima, Trustex, Ria and Premium Condoms | Ls Rubber Sdn Bhd | 1999 | — |
| 0 (this device) | K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | 2002 | — |
| +1 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| +2 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| +1 | K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | 2002 | — |
| +3 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +2 | K041837 | Innolatex Male Latex Condoms Colored and Scented | Innolatex Sdn. Bhd | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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 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 |
|---|---|---|---|
| * | K980964 | Maxima, Trustex, Ria and Premium CondomsSummary page 1…ansmission of sexually transmitted diseases. J,%["echnological Characteristics : The condom has the same technological characteristic as the ! predicate condom 510(K) # K980964. The only modification is to delete the brand names present in the S10(K) # K980964 and to add the new flavors which are approved… | 1999 |
What descends from it? (15)
See all 152 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?
- Its one ancestor has no recall.
- Of its descendants, K032227 (Ssl Americas, Inc., 2004) has gone furthest, with 7 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 condom is used for contraception and for
Prophylactic purposes (to help prevent pregnancy and the
transmission of sexually transmitted disease).
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/K020633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020633: Natural and Colored Latex Condom with Flavors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020633
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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