510(k) · Cleared
ClearedLatex Condoms W/Spermicidal Lubricant (Nonoxynol-9)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretex, Ltd. · HIS Condom
Cleared on May 18, 1995 after a 428-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 18, 1995
- Review
- 428 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK942858 Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9)Suretex, Ltd. · 1995
- Descendant · cites it directly · 3 of its ownK983320 Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted…Suretex Prophylactics (India), Ltd. · 1998 · Recalled
- 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 · 2 generations on · 0 of its ownK992081 Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK981621 Royale of Latex Condoms - Spermicidal Lubricant - Colored or…Suretex Prophylactics (India), Ltd. · 1998 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K983320Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted ColorsSuretex Prophylactics (India), Ltd. · 1998 · cites it directly3descendants
- 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 · 2 generations on0descendants
- K981621Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted ColorsSuretex Prophylactics (India), Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942858 | Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9) | Suretex, Ltd. | 1995 | — |
| +1 | K983320 | Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors | Suretex Prophylactics (India), Ltd. | 1998 | 1 |
| +1 | K030176 | Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing… | Suretex, Ltd. | 2003 | — |
| +2 | K033541 | Long Love Condom | Unidus Corp. | 2003 | — |
| +2 | K992081 | Various Ansell Tradenames or Private Label | Suretex Prophylactics (India), Ltd. | 1999 | — |
| +1 | K981621 | Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors | Suretex Prophylactics (India), Ltd. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983320 | Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors | 1998 | 3 |
| K030176 | Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant | 2003 | 1 |
| K981621 | Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors | 1998 | 0 |
| K972836 | Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors | 1997 | 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?
- Of its descendants, K983320 (Suretex Prophylactics (India), Ltd., 1998) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K942858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942858: Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942858
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026