510(k) · Cleared
ClearedExtremely Thin 003, ZERO ZERO THREE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Okamoto USA, Inc. · HIS Condom
Cleared on Jul 24, 2020 as substantially equivalent to K090259 (Okamoto USA, Inc., 2009) after a 303-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Jul 24, 2020
- Review
- 303 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872812 (1987). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK872812 Skinless-Skin, Pink Tint (Condom)Okamoto USA, Inc. · 1987
- 1 generation backK090259 Okamoto Ultra ThinOkamoto USA, Inc. · 2009
- This deviceK192669 Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK252622 Male Latex Condom HAOkamoto USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213921 Microthin Natural Rubber Latex CondomSuretex Limited · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872812 | Skinless-Skin, Pink Tint (Condom) | Okamoto USA, Inc. | 1987 | — |
| −1 | K090259 | Okamoto Ultra Thin | Okamoto USA, Inc. | 2009 | — |
| 0 (this device) | K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020 | — |
| +1 | K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K090259 | Okamoto Ultra ThinSummary page 4…Condom, now marketed as 0.04 ZERO ZERO FOUR® Company Name: OKAMOTO U.S.A., INC. Predicate Device 510(k) Document Control Number: K090259 The predicate device has not been subject to a design-related recall. Description of the Device: The device is a condom that is… | 2009 |
What descends from it? (2)
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?
- The line of descent spans 33 years and passes through 1 company; a new generation was cleared every 21.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252622 (Okamoto USA, Inc., 2026) 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. 2020, 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 contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
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/K192669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192669: Extremely Thin 003, ZERO ZERO THREE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192669
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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