510(k) · Cleared
Recalled · Class II · 2012Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors
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 Dec 11, 1998 as substantially equivalent to K942858 (Suretex, Ltd., 1995) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- HIS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932982 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932982 Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi)Sime Health, Ltd. · 1994
- This deviceK983320 Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted…Suretex Prophylactics (India), Ltd. · 1998
- Descendant · cites it directly · 1 of its ownK030176 Lifestyles, Contempo or Private Label-Male Latex Condom with…Suretex, Ltd. · 2003
- Descendant · 2 generations on · 0 of its ownK033541 Long Love CondomUnidus Corp. · 2003
- Descendant · cites it directly · 0 of its ownK992081 Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd. · 1999
Most influential descendants
Showing 3 of 3 · See all- K030176Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing LubricantSuretex, Ltd. · 2003 · cites it directly1descendant
- K033541Long Love CondomUnidus Corp. · 2003 · 2 generations on0descendants
- K992081Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932982 | Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi) | Sime Health, Ltd. | 1994 | — |
| 0 (this device) | K983320 | Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors | Suretex Prophylactics (India), Ltd. | 1998 | — |
| +1 | K030176 | Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing… | Suretex, Ltd. | 2003 | — |
| +2 | K033541 | Long Love Condom | Unidus Corp. | 2003 | — |
| +1 | 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 |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 2 | 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 |
|---|---|---|---|
| * | K942858 | Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9)Summary page 1…ce: Latex Condoms - silicone lubricated - Naturai and assorted colors in Royale brand or in any other private label. 3. Predicate Device information: Suretex Ltd., K# 942858A, Latex condoms with Spermicidai Lubricant. Sime Health Ltd., K# 932982, Spermicidal lubricated condoms (Essential, Mi Vida and J… | 1995 |
| * | K932982 | Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi)Summary page 1…n Royale brand or in any other private label. 3. Predicate Device information: Suretex Ltd., K# 942858A, Latex condoms with Spermicidai Lubricant. Sime Health Ltd., K# 932982, Spermicidal lubricated condoms (Essential, Mi Vida and Jiffi). 4. Device Description A condom with silicone lubricant is a she… | 1994 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2012 | Class II | Z-0717-2013 | Packaging | One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 intended use of this condom is for contraception and prophylactic purposes
(preventing transmission of venereal disease).
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/K983320 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983320: Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983320
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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