510(k) · Cleared
Recalled · Class II · 2013Lifestyles Zero Lubricated Latex Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Heathcare Products, LLC · HIS Condom
Cleared on May 8, 2012 as substantially equivalent to K103119 (Sheila Pickering PHD, 2011) after a 90-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- May 8, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- HIS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K952415 (1996). 17 ancestors in all, the oldest K890863 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK952415 Durex, Ramses, SheikLondon International U.S. Holdings, Inc. · 1996
- 4 generations backK983380 Durex Lubragel Latex CondomLondon Intl., LLC · 1998
- 3 generations backK032227 Durex Flavored Latex CondomSsl Americas, Inc. · 2004
- 2 generations backK081413 Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd. · 2008
- 1 generation backK103119 Billy Boy Male Latex CondomSheila Pickering PHD · 2011
- This deviceK120394 Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 2012
- Descendant · cites it directly · 0 of its ownK153016 aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952415 | Durex, Ramses, Sheik | London International U.S. Holdings, Inc. | 1996 | — |
| −4 | K983380 | Durex Lubragel Latex Condom | London Intl., LLC | 1998 | — |
| −3 | K032227 | Durex Flavored Latex Condom | Ssl Americas, Inc. | 2004 | — |
| −2 | K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | 2008 | — |
| −1 | K103119 | Billy Boy Male Latex Condom | Sheila Pickering PHD | 2011 | — |
| 0 (this device) | K120394 | Lifestyles Zero Lubricated Latex Condom | Ansell Heathcare Products, LLC | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 13.3 · 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 |
|---|---|---|---|
| * | K103119 | Billy Boy Male Latex CondomSummary page 1…Condom Common Name: Latex Condom Classification Condom (21 CFR 884.5300; Product Code HIS) Name: Predicate Device(s): Billy Boy Male Latex Condoms (K1031 19) Device Description: This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely finte… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153016 | aoni Natural Rubber Latex Condom | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2013 | Class II | Z-0838-2013 | Device Design | Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K153016 (Guangzhou Daming United Rubber Products, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103119.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 LifeStyles® Zero® condom is used for contraception and for
prophylactic purposes (to help prevent pregnancy and the transmission of sexually
transmitted diseases).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120394 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120394: Lifestyles Zero Lubricated Latex Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120394
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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