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 Jul 16, 2013 as substantially equivalent to K123300 (Becton, Dickinson & CO, 2013) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 2005. 11 later devices descend from it.
- Decided
- Jul 16, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K051899 (2005). 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 2 generations backK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
- 1 generation backK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
- This deviceK131358 BD Pen NeedleBecton, Dickinson & CO · 2013
- Descendant · cites it directly · 10 of its ownK162516 BD Pen NeedleBecton, Dickinson and Company · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK171982 Droplet Pen NeedleHtl-Strefa S.A · 2018
- Descendant · 2 generations on · 2 of its ownK182320 BD Contoured Base Pen NeedleBecton, Dickinson and Company · 2018
- Descendant · 2 generations on · 1 of its ownK213407 UltiCare Disposable Pen NeedlesUltimed Incorporated · 2021
- Descendant · 3 generations on · 0 of its ownK260739 Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K162516BD Pen NeedleBecton, Dickinson and Company · 2016 · cites it directly10descendants
- K171982Droplet Pen NeedleHtl-Strefa S.A · 2018 · 2 generations on3descendants
- K182320BD Contoured Base Pen NeedleBecton, Dickinson and Company · 2018 · 2 generations on2descendants
- K213407UltiCare Disposable Pen NeedlesUltimed Incorporated · 2021 · 2 generations on1descendant
- K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −2 | K100005 | BD Pen Needle | Becton, Dickinson and Co. | 2010 | — |
| −1 | K123300 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| 0 (this device) | K131358 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| +1 | K162516 | BD Pen Needle | Becton, Dickinson and Company | 2016 | 2 |
| +2 | K171982 | Droplet Pen Needle | Htl-Strefa S.A | 2018 | — |
| +2 | K182320 | BD Contoured Base Pen Needle | Becton, Dickinson and Company | 2018 | — |
| +2 | K213407 | UltiCare Disposable Pen Needles | Ultimed Incorporated | 2021 | — |
| +3 | K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K123300 | BD Pen NeedleSummary page 1…Lumen Classification: Class 11, 21 CFR 880.5570 FMI 3. Predicate Device: RD Pen Needles: " K123300, BD 316 and 326 Extra Thin Wall (XTW) Pen Needles with PentaPointTm * K100005 BD Pen Needle… | 2013 |
| * | K100005 | BD Pen NeedleSummary page 1…e: RD Pen Needles: " K123300, BD 316 and 326 Extra Thin Wall (XTW) Pen Needles with PentaPointTm * K100005 BD Pen Needle 326 x 4mm 15 === Pa… | 2010 |
| * | K051899 | BD Pen NeedleSummary page 2…* K100005 BD Pen Needle 326 x 4mm 15 * K051899 3lG x mm and the 3lG x 5mm Pen Needles Manufactured by: Becton, Dickinson and Company 4. Device Description: Like th… | 2005 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162516 | BD Pen Needle | 2016 | 10 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162516 (Becton, Dickinson and Company, 2016) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K123300.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
BD 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/K131358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131358: BD 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/K131358
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