510(k) · Cleared
ClearedBD Autoshield Duo Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 27, 2011 as substantially equivalent to K060007 (Becton, Dickinson & CO, 2006) after a 135-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.
- Decided
- Jul 27, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051899 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 1 generation backK060007 BD Autoshield Pen NeedleBecton, Dickinson & CO · 2006 · Recalled
- This deviceK110703 BD Autoshield Duo Pen NeedleBecton, Dickinson and Company · 2011
- Descendant · cites it directly · 1 of its ownK223286 BD AutoShield Duo™ Pen NeedleBecton, Dickinson and Company · 2022
- Descendant · 2 generations on · 0 of its ownK261266 MOWANA™ Auto DuoPentamaster Mediq SDN BHD · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −1 | K060007 | BD Autoshield Pen Needle | Becton, Dickinson & CO | 2006 | 1 |
| 0 (this device) | K110703 | BD Autoshield Duo Pen Needle | Becton, Dickinson and Company | 2011 | — |
| +1 | K223286 | BD AutoShield Duo™ Pen Needle | Becton, Dickinson and Company | 2022 | — |
| +2 | K261266 | MOWANA™ Auto Duo | Pentamaster Mediq SDN BHD | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K060007 | BD Autoshield Pen NeedleSummary page 1…umen Classification: Class 11, 21 CFR 880.5570 FMI 3. Predicate iDevice: BDAutoShield TM Pen Needle- K060007 M~anufactured by: Becton, Dickinson and Company… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223286 | BD AutoShield Duo™ Pen Needle | 2022 | 1 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K223286 (Becton, Dickinson and Company, 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K060007.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 BD AutoShield TM" Duo Pen Needle is intended for use with pen injector devices for the injection of drugs.
The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110703: BD Autoshield Duo Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110703
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