510(k) · Cleared
ClearedMOWANA™ Auto Duo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentamaster Mediq SDN BHD · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 17, 2026 as substantially equivalent to K223286 (Becton, Dickinson and Company, 2022) after a 154-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Sep 17, 2026
- Review
- 154 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051899 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 3 generations backK060007 BD Autoshield Pen NeedleBecton, Dickinson & CO · 2006 · Recalled
- 2 generations backK110703 BD Autoshield Duo Pen NeedleBecton, Dickinson and Company · 2011
- 1 generation backK223286 BD AutoShield Duo™ Pen NeedleBecton, Dickinson and Company · 2022
- This deviceK261266 MOWANA™ Auto DuoPentamaster Mediq SDN BHD · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −3 | K060007 | BD Autoshield Pen Needle | Becton, Dickinson & CO | 2006 | 1 |
| −2 | K110703 | BD Autoshield Duo Pen Needle | Becton, Dickinson and Company | 2011 | — |
| −1 | K223286 | BD AutoShield Duo™ Pen Needle | Becton, Dickinson and Company | 2022 | — |
| 0 (this device) | K261266 | MOWANA™ Auto Duo | Pentamaster Mediq SDN BHD | 2026 | — |
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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K223286 | BD AutoShield Duo™ Pen NeedleSummary page 5…880.5570 Product Code(s) FMI I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223286 BD AutoShield Duo FMI Device Description Summary 21 CFR 807.92(a)(4) MOWANA™ Auto Duo is a disposable single use sterile device… | 2022 |
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 21 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The hypodermic pen needle is intended to be used with pen injector device for subcutaneous injection of medications
including but not limited to insulin.
The device has a passive dual safety mechanism that activates to cover both ends of the pen needle upon use to prevent
accidental needle stick injuries.
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/K261266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261266: MOWANA™ Auto Duo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261266
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026