510(k) · Cleared
ClearedFAMA Male Latex Condoms
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 Aug 5, 2022 as substantially equivalent to K162919 (Zhejiang Xiangban Latex Products Co., Ltd., 2017) after a 158-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 5, 2022
- Review
- 158 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K897129 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK897129 Condoms (Multiple Brands)Sagami, Inc. · 1990
- 3 generations backK071313 Trojan-Enz BrandChurch & Dwight Co., Inc. · 2007
- 2 generations backK083817 M. Dior BrandSuzhou Colour-Way Enterprise Development Co., Ltd. · 2009
- 1 generation backK162919 Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. · 2017
- This deviceK220576 FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK262108 FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male…Shanghai Personage Hygiene Products Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK232279 LifeStyles NRL Textured CondomSuretex Limited · 2023
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 |
|---|---|---|---|---|---|
| −4 | K897129 | Condoms (Multiple Brands) | Sagami, Inc. | 1990 | — |
| −3 | K071313 | Trojan-Enz Brand | Church & Dwight Co., Inc. | 2007 | — |
| −2 | K083817 | M. Dior Brand | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2009 | — |
| −1 | K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | 2017 | — |
| 0 (this device) | K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022 | — |
| +1 | K262108 | FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex… | Shanghai Personage Hygiene Products Co., Ltd. | 2026 | — |
| +1 | K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K162919 | Male Latex CondomsSummary page 4…t Code: HIS (Condom) 5. Predicate Device Information Device Name: Male Latex Condoms 510(k) Number: K162919 Manufacturer: Zhejiang Xiangban Latex Products Co., Ltd. Regulatory Class: Class II… | 2017 |
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 32 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K262108 (Shanghai Personage Hygiene Products Co., Ltd., 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. 2022, 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 Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the 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/K220576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220576: FAMA Male Latex Condoms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220576
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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