510(k) · Cleared
ClearedBD 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 Dec 8, 2021 as substantially equivalent to K182320 (Becton, Dickinson and Company, 2018) after a 79-day review. Its family tree reaches back 6 generations to 2005.
- Decided
- Dec 8, 2021
- Review
- 79 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- 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 deviceK213156 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) | K213156 | 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…: FMI (Needle, Hypodermic, Single Lumen) Legally marketed predicate devices to which substantial equivalence is being claimed: BD Contoured Base Pen Needle (K182320) Reason for Submission: The purpose of this submission is to market a new BD Pen Needle size that utilizes all the same compon… | 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)
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 16 years and passes through 3 companies; a new generation was cleared every 3.0 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 as stated in the FDA summary.
https://510kreport.com/device/K213156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213156: BD Nano 2nd Gen Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213156
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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