510(k) · Cleared
ClearedVarious Ansell Tradenames or Private Label
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretex Prophylactics (India), Ltd. · HIS Condom
Cleared on Aug 19, 1999 as substantially equivalent to K983320 (Suretex Prophylactics (India), Ltd., 1998) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Aug 19, 1999
- Review
- 59 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932982 (1994). 4 ancestors in all, the oldest K932983 (1994). No later device cites it as a predicate yet.
- 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 deviceK992081 Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd. · 1999
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) | K992081 | Various Ansell Tradenames or Private Label | Suretex Prophylactics (India), Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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…CFR §884.5300) Predicate Device: Suretex Prophylactics (India) Limited, Royale® Brand Latex Condoms (Silicone) Natural or Assorted Colors 510(k) Document Control Number K983320 Sime Health Ltd., Lubricated (Silicone) Latex Condom (Coloured) 510(k) Document Control Number K932983 Description of the Devic… | 1998 |
| * | K932983 | Colored Condoms (Essentials, MI Vida, Jiffi)Summary page 1…licone) Natural or Assorted Colors 510(k) Document Control Number K983320 Sime Health Ltd., Lubricated (Silicone) Latex Condom (Coloured) 510(k) Document Control Number K932983 Description of the Device: This condom is a male contraceptive and prophylactic device which is fabricated of a natural rubber… | 1994 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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 Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. 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…
Read the full statement (137 words)
The Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992081: Various Ansell Tradenames or Private Label.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992081
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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