510(k) · Cleared
Recalled · Class II · 2024BD Nano 2nd Gen 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 Nov 19, 2021 as substantially equivalent to K182320 (Becton, Dickinson and Company, 2018) after a 144-day review. Its family tree reaches back 6 generations to 2005. It has been recalled 2 times.
- Decided
- Nov 19, 2021
- Review
- 144 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K051899 (2005). No later device cites it as a predicate yet.
- Root · 6 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 5 generations backK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
- 4 generations backK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
- 3 generations backK131358 BD Pen NeedleBecton, Dickinson & CO · 2013
- 2 generations backK162516 BD Pen NeedleBecton, Dickinson and Company · 2016 · Recalled
- 1 generation backK182320 BD Contoured Base Pen NeedleBecton, Dickinson and Company · 2018
- This deviceK212015 BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −5 | K100005 | BD Pen Needle | Becton, Dickinson and Co. | 2010 | — |
| −4 | K123300 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| −3 | K131358 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| −2 | K162516 | BD Pen Needle | Becton, Dickinson and Company | 2016 | 2 |
| −1 | K182320 | BD Contoured Base Pen Needle | Becton, Dickinson and Company | 2018 | — |
| 0 (this device) | K212015 | BD Nano 2nd Gen Pen Needle | Becton, Dickinson and Company | 2021 | — |
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 |
|---|---|---|---|
| * | K182320 | BD Contoured Base Pen NeedleSummary page 4…Product Code: FMI (hypodermic single lumen needle) Legally marketed predicate device to which substantial equivalence is being claimed: K182320: BD Contoured Base Pen Needle Device Description: The BD Nano™ 2nd Gen Pen Needle is designed for use with pen injectors for su… | 2018 |
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 |
|---|---|---|---|---|
| Jun 18, 2024 | Class II | Z-2424-2024 | Process control | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed. |
| Jul 26, 2023 | Class II | Z-3179-2026 | Nonconforming Material/Component | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K182320.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Becton Dickinson Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
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/K212015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212015: BD Nano 2nd Gen 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/K212015
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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