510(k) · Cleared
ClearedKimono Microthin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mayer Laboratories · HIS Condom
Cleared on Nov 8, 1995 after a 329-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 8, 1995
- Review
- 329 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK946374 Kimono MicrothinMayer Laboratories · 1995
- Descendant · cites it directly · 3 of its ownK090259 Okamoto Ultra ThinOkamoto USA, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK192669 Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK252622 Male Latex Condom HAOkamoto USA, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK213921 Microthin Natural Rubber Latex CondomSuretex Limited · 2022
- Descendant · cites it directly · 0 of its ownK113686 Kimono Microthin with Aqua Lube, Reality Ultra LubricatedMayer Laboratories, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K090259Okamoto Ultra ThinOkamoto USA, Inc. · 2009 · cites it directly3descendants
- K192669Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 2020 · 2 generations on2descendants
- K252622Male Latex Condom HAOkamoto USA, Inc. · 2026 · 3 generations on0descendants
- K213921Microthin Natural Rubber Latex CondomSuretex Limited · 2022 · 3 generations on0descendants
- K113686Kimono Microthin with Aqua Lube, Reality Ultra LubricatedMayer Laboratories, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946374 | Kimono Microthin | Mayer Laboratories | 1995 | — |
| +1 | K090259 | Okamoto Ultra Thin | Okamoto USA, Inc. | 2009 | — |
| +2 | K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020 | — |
| +3 | K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026 | — |
| +3 | K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | 2022 | — |
| +1 | K113686 | Kimono Microthin with Aqua Lube, Reality Ultra Lubricated | Mayer Laboratories, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 13.3 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 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, K090259 (Okamoto USA, Inc., 2009) has gone furthest, with 3 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/K946374 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946374: Kimono Microthin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946374
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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