510(k) · Cleared
ClearedLatex Condoms Colour with Spermicidal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reddy Medtech Health Products, Ltd. · LTZ Condom With Nonoxynol-9
Cleared on Feb 9, 1998 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 9, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- LTZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974324 Latex Condoms Colour with Spermicidal LubricantReddy Medtech Health Products, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK993782 Simplex Condoms, Latex Condoms-with Spermicidal Lubricant…P.T. Vonix Latexindo Condom (Rubber) Mfg. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993782Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9)P.T. Vonix Latexindo Condom (Rubber) Mfg. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974324 | Latex Condoms Colour with Spermicidal Lubricant | Reddy Medtech Health Products, Ltd. | 1998 | — |
| +1 | K993782 | Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9) | P.T. Vonix Latexindo Condom (Rubber) Mfg. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993782 | Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9) | 2000 | 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, K993782 (P.T. Vonix Latexindo Condom (Rubber) Mfg., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LTZ devicesLTZ Condom With Nonoxynol-9: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTZ
FDA has decided no LTZ device since 2007.
Median 510(k) review, days · LTZ
Too few LTZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LTZ
No recall names LTZ since 2007.
Adverse event reports per year · LTZ
1in 2014
MAUDE reports naming product code LTZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
If used properly, condoms will help to 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. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974324: Latex Condoms Colour with Spermicidal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974324
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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