510(k) · Cleared
Recalled · Class II · 2018Durex Synthetic Polyisoprene Male Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas, Inc. · MOL Condom, Synthetic
Cleared on Jun 19, 2008 as substantially equivalent to K980319 (London Intl., LLC, 1998) and 1 other predicate after a 318-day review. Its family tree reaches back 1 generation to 1998. It has been recalled 4 times.
- Decided
- Jun 19, 2008
- Review
- 318 days
- Class
- Class II
- Product code
- MOL
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980319 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980319 Durex Ultra ComfortLondon Intl., LLC · 1998
- This deviceK072169 Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980319 | Durex Ultra Comfort | London Intl., LLC | 1998 | — |
| 0 (this device) | K072169 | Durex Synthetic Polyisoprene Male Condom | Ssl Americas, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 MOL? 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 MOL device
- #1 K252158 Sagami Original 002 Polyurethane Male Condomscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K980319 | Durex Ultra ComfortSummary page 1…male condom F. Classification Name Condom non-latex ( 21 CFR 884.5300, Product code M-OL) G. Predicated Device Durex Ultra Comfort Latex Rubber Condom [5 10(k) Number K9803 19] Biogel Skinsense PI surgeons glove [5 10(k) Number K0501 84] H. Description of the Device This condom is made of a synthetic… | 1998 |
| * | K050184 | Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveSummary page 1…R 884.5300, Product code M-OL) G. Predicated Device Durex Ultra Comfort Latex Rubber Condom [5 10(k) Number K9803 19] Biogel Skinsense PI surgeons glove [5 10(k) Number K0501 84] H. Description of the Device This condom is made of a synthetic polyisoprene rubber sheath, which completely covers the peni… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2018 | Class II | Z-0994-2019 | Under Investigation by firm | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. |
| Dec 19, 2018 | Class II | Z-0993-2019 | Under Investigation by firm | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. |
| Aug 6, 2018 | Class II | Z-0091-2019 | Nonconforming Material/Component | Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life |
| Jul 23, 2018 | Class II | Z-3241-2018 | Under Investigation by firm | The products failed the filed specification of 1.0kPa for Burst Pressure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K980319.
How does its category compare?
All MOL devicesMOL Condom, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MOL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOL
244in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOL
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOL
4in 2025
MAUDE reports naming product code MOL, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 2 | — | 0 | 9 |
| 2018 | 1 | — | 3 | 11 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 3 | 244 | 0 | 2 |
| 2025 | 2 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072169 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072169: Durex Synthetic Polyisoprene Male Condom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072169
Report an extraction error
Are you the manufacturer?
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