510(k) · Cleared
ClearedModification to BD Ultra-Fine Iii 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 Jun 24, 2003 after a 69-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jun 24, 2003
- Review
- 69 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK031200 Modification to BD Ultra-Fine Iii Pen NeedleBecton, Dickinson & CO · 2003
- Descendant · cites it directly · 4 of its ownK143437 Droplet Pen NeedlesHtl-Strefa S.A · 2015
- Descendant · 2 generations on · 3 of its ownK171982 Droplet Pen NeedleHtl-Strefa S.A · 2018
- Descendant · 3 generations on · 0 of its ownK260739 Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK230635 Pen NeedleJiangsu Caina Medical Co.,Ltd · 2023
- Descendant · 3 generations on · 0 of its ownK192464 Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K143437Droplet Pen NeedlesHtl-Strefa S.A · 2015 · cites it directly4descendants
- K171982Droplet Pen NeedleHtl-Strefa S.A · 2018 · 2 generations on3descendants
- K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026 · 3 generations on0descendants
- K230635Pen NeedleJiangsu Caina Medical Co.,Ltd · 2023 · 3 generations on0descendants
- K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031200 | Modification to BD Ultra-Fine Iii Pen Needle | Becton, Dickinson & CO | 2003 | — |
| +1 | K143437 | Droplet Pen Needles | Htl-Strefa S.A | 2015 | — |
| +2 | K171982 | Droplet Pen Needle | Htl-Strefa S.A | 2018 | — |
| +3 | K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026 | — |
| +3 | K230635 | Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2023 | — |
| +3 | K192464 | Injection Pen Needle | Gangan Medical Technology Jiangsu Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 Ultra-Fine Pen Needle Named without a submission number | |
| * | — | BD Ultra-Fine I11 Pen Needle Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K143437 (Htl-Strefa S.A, 2015) has gone furthest, with 4 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 the subcutaneous injection of insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031200: Modification to BD Ultra-Fine Iii 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/K031200
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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