510(k) · Cleared
ClearedBD Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 13, 2005 after a 62-day review. The FDA summary names its predicate without a number. 87 later devices descend from it.
- Decided
- Sep 13, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
87 later devices descend from it, 14 citing it directly.
- This deviceK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- Descendant · cites it directly · 59 of its ownK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
- Descendant · 2 generations on · 21 of its ownK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- Descendant · cites it directly · 20 of its ownK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
- Descendant · cites it directly · 20 of its ownK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- Descendant · 2 generations on · 18 of its ownK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K100005BD Pen NeedleBecton, Dickinson and Co. · 2010 · cites it directly59descendants
- K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012 · 2 generations on21descendants
- K123300BD Pen NeedleBecton, Dickinson & CO · 2013 · cites it directly20descendants
- K120690Insulin Pen NeedleTiger Medical Products, Ltd. · 2012 · cites it directly20descendants
- K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| +1 | K100005 | BD Pen Needle | Becton, Dickinson and Co. | 2010 | — |
| +2 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| +1 | K123300 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| +1 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| +2 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | — | BD Pen Needles Named without a submission number | |
| * | — | Disetronic PenFine Injection Pen Needles Named without a submission number |
What descends from it? (87)
See all 8714 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100005 | BD Pen Needle | 2010 | 59 |
| K123300 | BD Pen Needle | 2013 | 20 |
| K120690 | Insulin Pen Needle | 2012 | 20 |
| K060007 | BD Autoshield Pen Needle | 2006 | 18 |
| K062500 | Flexpen Needle | 2006 | 17 |
| K090111 | Flexpen Needle | 2010 | 16 |
| K131358 | BD Pen Needle | 2013 | 11 |
| K063466 | Top Fine | 2007 | 11 |
| K162516 | BD Pen Needle | 2016 | 10 |
| K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5') | 2010 | 4 |
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?
- Of its descendants, K100005 (Becton, Dickinson and Co., 2010) has gone furthest, with 59 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 device for
subcutaneous injection of drugs, including insulin and exenatide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051899: BD Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051899
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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