510(k) · Cleared
ClearedM. Dior Brand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Colour-Way Enterprise Development Co., Ltd. · HIS Condom
Cleared on Sep 16, 2009 as substantially equivalent to K071313 (Church & Dwight Co., Inc., 2007) after a 268-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it.
- Decided
- Sep 16, 2009
- Review
- 268 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K897129 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK897129 Condoms (Multiple Brands)Sagami, Inc. · 1990
- 1 generation backK071313 Trojan-Enz BrandChurch & Dwight Co., Inc. · 2007
- This deviceK083817 M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK162919 Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK220576 FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK262108 FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male…Shanghai Personage Hygiene Products Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK232279 LifeStyles NRL Textured CondomSuretex Limited · 2023
- Descendant · cites it directly · 0 of its ownK150828 O-RING CondomO-Ring Products, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K162919Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. · 2017 · cites it directly3descendants
- K220576FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. · 2022 · 2 generations on2descendants
- K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms –…Shanghai Personage Hygiene Products Co., Ltd. · 2026 · 3 generations on0descendants
- K232279LifeStyles NRL Textured CondomSuretex Limited · 2023 · 3 generations on0descendants
- K150828O-RING CondomO-Ring Products, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K897129 | Condoms (Multiple Brands) | Sagami, Inc. | 1990 | — |
| −1 | K071313 | Trojan-Enz Brand | Church & Dwight Co., Inc. | 2007 | — |
| 0 (this device) | K083817 | M. Dior Brand | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2009 | — |
| +1 | K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | 2017 | — |
| +2 | K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022 | — |
| +3 | K262108 | FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex… | Shanghai Personage Hygiene Products Co., Ltd. | 2026 | — |
| +3 | K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023 | — |
| +1 | K150828 | O-RING Condom | O-Ring Products, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K071313 | Trojan-Enz BrandSummary page 1…Men Classification Name: Condom (21· CFR 884.5300) Predicate Device: Latex Lubricated Condom 510(k) # K071313 Description of the Device: The condoms are made of a natural rubber latex sheath, whi… | 2007 |
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162919 (Zhejiang Xiangban Latex Products Co., Ltd., 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K071313.
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?
M. Dior Brand Latex Condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
The device is for over the counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083817: M. Dior Brand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083817
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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