510(k) · Cleared
ClearedSimplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
P.T. Vonix Latexindo Condom (Rubber) Mfg. · HIS Condom
Cleared on Feb 2, 2000 as substantially equivalent to K974324 (Reddy Medtech Health Products, Ltd., 1998) after an 86-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 2, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974324 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974324 Latex Condoms Colour with Spermicidal LubricantReddy Medtech Health Products, Ltd. · 1998
- This deviceK993782 Simplex Condoms, Latex Condoms-with Spermicidal Lubricant…P.T. Vonix Latexindo Condom (Rubber) Mfg. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974324 | Latex Condoms Colour with Spermicidal Lubricant | Reddy Medtech Health Products, Ltd. | 1998 | — |
| 0 (this device) | K993782 | Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9) | P.T. Vonix Latexindo Condom (Rubber) Mfg. | 2000 | — |
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 13.2 · 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? (1)
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 |
|---|---|---|---|
| * | K974324 | Latex Condoms Colour with Spermicidal LubricantSummary page 1…02 Vijay Mahal (Applicant) Vineel Enterprises Phone:617-973-7157 November 4", 1999 Simplex Condoms Latex Condom Condom (21 CFR 884.5300) Condom with Nonoxynol-9 510K# K974324 This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This co… | 1998 |
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?
- Its one ancestor has no recall.
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 Snmplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics 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 Snmplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics 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/K993782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993782: Simplex Condoms, Latex Condoms-with 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/K993782
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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