510(k) · Cleared
ClearedFAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Personage Hygiene Products Co., Ltd. · HIS Condom
Cleared on Sep 21, 2026 as substantially equivalent to K220576 (Shanghai Personage Hygiene Products Co., Ltd., 2022) after a 90-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Sep 21, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K897129 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK897129 Condoms (Multiple Brands)Sagami, Inc. · 1990
- 4 generations backK071313 Trojan-Enz BrandChurch & Dwight Co., Inc. · 2007
- 3 generations backK083817 M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009
- 2 generations backK162919 Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. · 2017
- 1 generation backK220576 FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. · 2022
- This deviceK262108 FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male…Shanghai Personage Hygiene Products Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K897129 | Condoms (Multiple Brands) | Sagami, Inc. | 1990 | — |
| −4 | K071313 | Trojan-Enz Brand | Church & Dwight Co., Inc. | 2007 | — |
| −3 | K083817 | M. Dior Brand | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2009 | — |
| −2 | K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | 2017 | — |
| −1 | K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022 | — |
| 0 (this device) | K262108 | FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex… | Shanghai Personage Hygiene Products Co., Ltd. | 2026 | — |
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 K252622 Male Latex Condom HAscore 11.9 · 3 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 |
|---|---|---|---|
| * | K220576 | FAMA Male Latex CondomsSummary page 6…K262108 Page 2 of 4 510(k) Submission 4. Identification of Predicate Device K220576: FAMA Male Latex Condoms The predicate device has not been subject to a design related recall. 5. Description of the Device FAM… | 2022 |
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 36 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K220576.
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 FAMA/MO/Mingliu Male Natural Rubber Latex Condoms — Aqueous Lubricant are used for contraception and prophylactic purposes (to help prevent pregnancy and 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/K262108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262108: FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262108
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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