510(k) · Cleared
ClearedDurex Penck III Regular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rb Health (Us), LLC · HIS Condom
Cleared on Oct 12, 2022 as substantially equivalent to K200672 (Rb Health (Us), LLC, 2020) after a 90-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Oct 12, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941258 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK941258 Latex CondomSuretex, Ltd. · 1995 · Recalled
- 2 generations backK163107 Lifestyles Zero Lubricated Latex Male CondomAnsell Healthcare Products, LLC · 2017
- 1 generation backK200672 Durex Penck Standard, Durex Penck XLRb Health (Us), LLC · 2020
- This deviceK222068 Durex Penck III RegularRb Health (Us), LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941258 | Latex Condom | Suretex, Ltd. | 1995 | 1 |
| −2 | K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | 2017 | — |
| −1 | K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | 2020 | — |
| 0 (this device) | K222068 | Durex Penck III Regular | Rb Health (Us), LLC | 2022 | — |
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 |
|---|---|---|---|
| * | K200672 | Durex Penck Standard, Durex Penck XLSummary page 4…Class II 5. Predicate Device Information Device Name: Durex Penck Standard, Durex Penck XL 510(k) Number: K200672 Sponsor: RB Health (US) LLC Manufacturer: Reckitt Benckiser LLC… | 2020 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K200672.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222068: Durex Penck III Regular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222068
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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