510(k) · Cleared
ClearedCondoms (Multiple Brands)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sagami, Inc. · HIS Condom
Cleared on May 16, 1990 after a 141-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- May 16, 1990
- Review
- 141 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK897129 Condoms (Multiple Brands)Sagami, Inc. · 1990
- Descendant · cites it directly · 13 of its ownK071313 Trojan-Enz BrandChurch & Dwight Co., Inc. · 2007
- Descendant · cites it directly · 8 of its ownK071272 Trojan Thintensity Brand Male Latex CondomChurch & Dwight Co., Inc. · 2007
- Descendant · 2 generations on · 7 of its ownK073016 Trojan Thintensity Brand Male Latex Condom Lubricated with…Church & Dwight Co., Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- Descendant · 2 generations on · 5 of its ownK083817 M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K071313Trojan-Enz BrandChurch & Dwight Co., Inc. · 2007 · cites it directly13descendants
- K071272Trojan Thintensity Brand Male Latex CondomChurch & Dwight Co., Inc. · 2007 · cites it directly8descendants
- K073016Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm…Church & Dwight Co., Inc. · 2007 · 2 generations on7descendants
- K103119Billy Boy Male Latex CondomSheila Pickering PHD · 2011 · 2 generations on5descendants
- K083817M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K897129 | Condoms (Multiple Brands) | Sagami, Inc. | 1990 | — |
| +1 | K071313 | Trojan-Enz Brand | Church & Dwight Co., Inc. | 2007 | — |
| +1 | K071272 | Trojan Thintensity Brand Male Latex Condom | Church & Dwight Co., Inc. | 2007 | — |
| +2 | K073016 | Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and… | Church & Dwight Co., Inc. | 2007 | — |
| +2 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| +2 | K083817 | M. Dior Brand | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 13.2 · 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? (17)
See all 172 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, K071313 (Church & Dwight Co., Inc., 2007) has gone furthest, with 13 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/K897129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K897129: Condoms (Multiple Brands).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K897129
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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