510(k) · Cleared
ClearedMint Scented Condoms
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schmid Laboratories, Inc. · HIS Condom
Cleared on Jun 7, 1990 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 7, 1990
- Review
- 115 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK900679 Mint Scented CondomsSchmid Laboratories, Inc. · 1990
- Descendant · cites it directly · 0 of its ownK052959 Durex Male Colored Latex Condoms with Scented LubricantsSsl Americas · 2006
- Descendant · cites it directly · 0 of its ownK042958 Durex Play Tingling LubricantSsl Americas, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK042470 Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling…Ssl Americas, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K052959Durex Male Colored Latex Condoms with Scented LubricantsSsl Americas · 2006 · cites it directly0descendants
- K042958Durex Play Tingling LubricantSsl Americas, Inc. · 2005 · cites it directly0descendants
- K042470Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' CondomSsl Americas, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900679 | Mint Scented Condoms | Schmid Laboratories, Inc. | 1990 | — |
| +1 | K052959 | Durex Male Colored Latex Condoms with Scented Lubricants | Ssl Americas | 2006 | — |
| +1 | K042958 | Durex Play Tingling Lubricant | Ssl Americas, Inc. | 2005 | — |
| +1 | K042470 | Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure'… | Ssl Americas, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 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?
- Of its descendants, K052959 (Ssl Americas, 2006) has gone furthest, with 0 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 | — |
https://510kreport.com/device/K900679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900679: Mint Scented Condoms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900679
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026