510(k) · Cleared
ClearedKwikeze Male Condom Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Condax, LLC · HIS Condom
Cleared on Nov 14, 2003 as substantially equivalent to K874383 (Arcon Corp., 1988) after a 228-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Nov 14, 2003
- Review
- 228 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874383 (1988). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K052206Zeus Male Condom ApplicatorCondax, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874383 | Mentor Plus (Condom) | Arcon Corp. | 1988 | 1 |
| 0 (this device) | K031007 | Kwikeze Male Condom Applicator | Condax, LLC | 2003 | — |
| +1 | K052206 | Zeus Male Condom Applicator | Condax, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K874383 | Mentor Plus (Condom)Summary page 1…Applicator Common Name: Condom Applicator Classification Name: Not Classified Predicate Device: Mentor Plus Condom; K874383 Description of Device: The KwikezeTM Male Condom Applicator is an elliptical ring made of… | 1988 |
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 |
|---|---|---|---|
| K052206 | Zeus Male Condom Applicator | 2006 | 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?
- Its one ancestor has a recall.
- Of its descendants, K052206 (Condax, LLC, 2006) 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 | — |
What is it indicated for?
The Kwikeze Male Condom Applicator facilitates correct positioning
(donning) of a male latex condom prior to sexual intercourse. The
condom is used for contraceptive and for prophylactic purposes (to help
prevent pregnancy and the transmission of sexually transmitted
diseases)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K031007: Kwikeze Male Condom Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031007
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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