510(k) · Cleared
ClearedColored Condoms (Essentials, MI Vida, Jiffi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sime Health, Ltd. · HIS Condom
Cleared on Jul 7, 1994 after a 384-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 7, 1994
- Review
- 384 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK932983 Colored Condoms (Essentials, MI Vida, Jiffi)Sime Health, Ltd. · 1994
- Descendant · cites it directly · 0 of its ownK023129 Unidus Male Latex Condom (Yellow, Pink, Green & Black)Unidus Corp. · 2002
- Descendant · cites it directly · 0 of its ownK992081 Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK971132 Royale Brand Latex Condoms (Silicone)-Colored/Assorted ColorsG. Premjee (Usa), Inc. · 1997 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K023129Unidus Male Latex Condom (Yellow, Pink, Green & Black)Unidus Corp. · 2002 · cites it directly0descendants
- K992081Various Ansell Tradenames or Private LabelSuretex Prophylactics (India), Ltd. · 1999 · cites it directly0descendants
- K971132Royale Brand Latex Condoms (Silicone)-Colored/Assorted ColorsG. Premjee (Usa), Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932983 | Colored Condoms (Essentials, MI Vida, Jiffi) | Sime Health, Ltd. | 1994 | — |
| +1 | K023129 | Unidus Male Latex Condom (Yellow, Pink, Green & Black) | Unidus Corp. | 2002 | — |
| +1 | K992081 | Various Ansell Tradenames or Private Label | Suretex Prophylactics (India), Ltd. | 1999 | — |
| +1 | K971132 | Royale Brand Latex Condoms (Silicone)-Colored/Assorted Colors | G. Premjee (Usa), Inc. | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 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 13.3 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023129 (Unidus Corp., 2002) has gone furthest, with 0 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/K932983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932983: Colored Condoms (Essentials, MI Vida, Jiffi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932983
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026