510(k) · Cleared
Clearedaoni Natural Rubber Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Daming United Rubber Products, Ltd. · HIS Condom
Cleared on Oct 20, 2016 as substantially equivalent to K120394 (Ansell Heathcare Products, LLC, 2012) after a 371-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 20, 2016
- Review
- 371 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K952415 (1996). 18 ancestors in all, the oldest K890863 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 5 generations backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- 4 generations backK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- 3 generations backK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- 2 generations backK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- 1 generation backK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012 · Recalled
- This deviceK153016 aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −5 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| −4 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| −3 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| −2 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| −1 | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | 1 |
| 0 (this device) | K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2007 | 3 | 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 |
|---|---|---|---|
| * | K120394 | Lifestyles Zero Lubricated Latex CondomSummary page 4…HIS – Condom Classification: Class II Predicate Device: LifeStyles Zero Lubricated Latex Condom 510(k) # K120394 Predicate has not been subject to a design-related recall Description of the Device: aoni Natu… | 2012 |
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 20 years and passes through 7 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 18 ancestors has a recall of any class.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
aoni Natural Rubber Latex Condom [Smooth/Dotted/Combined]
a) Smooth 52mm/54mm/55mm natural
b) Dotted 52mm natural
c) Combined [smooth+girdling] 52mm natural
d) Combined [dotted+girdling] 52mm natural
The Condom is used for contraception and for prophylactic purpose ( 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/K153016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153016: aoni Natural Rubber Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153016
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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