510(k) · Cleared
ClearedMale Latex Condom HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Okamoto USA, Inc. · HIS Condom
Cleared on May 4, 2026 as substantially equivalent to K192669 (Okamoto USA, Inc., 2020) after a 258-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- May 4, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872812 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872812 Skinless-Skin, Pink Tint (Condom)Okamoto USA, Inc. · 1987
- 2 generations backK090259 Okamoto Ultra ThinOkamoto USA, Inc. · 2009
- 1 generation backK192669 Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 2020
- This deviceK252622 Male Latex Condom HAOkamoto USA, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872812 | Skinless-Skin, Pink Tint (Condom) | Okamoto USA, Inc. | 1987 | — |
| −2 | K090259 | Okamoto Ultra Thin | Okamoto USA, Inc. | 2009 | — |
| −1 | K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020 | — |
| 0 (this device) | K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K192669 | Extremely Thin 003, ZERO ZERO THREESummary page 5…Condom Regulation Number: 21 CFR 884.5300 Product Code: HIS (condom) Regulatory Class: Class II IV. Predicate Device Submission Number: K192669 Device Trade Name: Extremely Thin 003, ZERO ZERO THREE The predicate device has not been subject to a design related recall. V.… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 39 years and passes through 1 company; a new generation was cleared every 11.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K192669.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Male Latex Condom HA is used for contraceptive and prophylactic purposes (preventing transmission of sexually transmitted infections).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252622: Male Latex Condom HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252622
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026