510(k) · Cleared
ClearedOkamoto Ultra Thin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Okamoto USA, Inc. · HIS Condom
Cleared on Mar 31, 2009 as substantially equivalent to K872812 (Okamoto USA, Inc., 1987) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.
- Decided
- Mar 31, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872812 (1987). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK872812 Skinless-Skin, Pink Tint (Condom)Okamoto USA, Inc. · 1987
- This deviceK090259 Okamoto Ultra ThinOkamoto USA, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK192669 Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK252622 Male Latex Condom HAOkamoto USA, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK213921 Microthin Natural Rubber Latex CondomSuretex Limited · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872812 | Skinless-Skin, Pink Tint (Condom) | Okamoto USA, Inc. | 1987 | — |
| 0 (this device) | K090259 | Okamoto Ultra Thin | Okamoto USA, Inc. | 2009 | — |
| +1 | K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020 | — |
| +2 | K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026 | — |
| +2 | K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K872812 | Skinless-Skin, Pink Tint (Condom)Summary page 1…(21 CFR §884.5300) 1) Brand Name: BEYOND SEVENs, CROWN" Company Name:. OKAMOTO INDUSTRIES, INC. 510(k) Document control Number: K8728121A *'Beyond~event aed Cmwn(I) are under dhe same 510(k) Number 2) Brand Name: KIMOTO MICRO THI… | 1987 |
| * | K946374 | Kimono MicrothinSummary page 1…e 510(k) Number 2) Brand Name: KIMOTO MICRO THINO Company Name: SAGAMI RUBBER INDUSTRIES CO., LTD. 510(k) Document Control Number K946374 Decminof the Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a close… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192669 | Extremely Thin 003, ZERO ZERO THREE | 2020 | 2 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K192669 (Okamoto USA, Inc., 2020) has gone furthest, with 2 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. 2009, 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 condom is used for contraceptive and for prophylactic purposes (preventing transmission of
sexually transmitted infections).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090259: Okamoto Ultra Thin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090259
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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