510(k) · Cleared
ClearedLifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretex, Ltd. · HIS Condom
Cleared on Apr 17, 2003 as substantially equivalent to K983320 (Suretex Prophylactics (India), Ltd., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Apr 17, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932982 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932982 Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi)Sime Health, Ltd. · 1994
- 1 generation backK983320 Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted…Suretex Prophylactics (India), Ltd. · 1998 · Recalled
- This deviceK030176 Lifestyles, Contempo or Private Label-Male Latex Condom with…Suretex, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK033541 Long Love CondomUnidus Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033541Long Love CondomUnidus Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932982 | Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi) | Sime Health, Ltd. | 1994 | — |
| −1 | K983320 | Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors | Suretex Prophylactics (India), Ltd. | 1998 | 1 |
| 0 (this device) | K030176 | Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing… | Suretex, Ltd. | 2003 | — |
| +1 | K033541 | Long Love Condom | Unidus Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K983320 | Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted ColorsSummary page 1…(India) Limited, Royale Brand Latex Condoms (Silicone) Natural or Assorted Colors 5 10(k) Document Control Number K983320 Suretex Ltd., Latex Condoms with Spermicidal Lubricant (Natural or Assor… | 1998 |
| * | K942858 | Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9)Summary page 1…retex Ltd., Latex Condoms with Spermicidal Lubricant (Natural or Assorted Colors) 5 10(k) Document Control Number K942858 Description of the Device: ._ These condoms are male cont… | 1995 |
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 |
|---|---|---|---|
| K033541 | Long Love Condom | 2003 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K033541 (Unidus Corp., 2003) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K983320.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
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, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom…
Read the full statement (159 words)
The Lifestyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030176 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030176: Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030176
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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