510(k) · Cleared
Recalled · Class II · 2021BD 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 9, 2016 as substantially equivalent to K051899 (Becton, Dickinson & CO, 2005) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 2005. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 9, 2016
- Review
- 91 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K051899 (2005). 10 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 3 generations backK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
- 2 generations backK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
- 1 generation backK131358 BD Pen NeedleBecton, Dickinson & CO · 2013
- This deviceK162516 BD Pen NeedleBecton, Dickinson and Company · 2016
- Descendant · cites it directly · 3 of its ownK171982 Droplet Pen NeedleHtl-Strefa S.A · 2018
- Descendant · cites it directly · 2 of its ownK182320 BD Contoured Base Pen NeedleBecton, Dickinson and Company · 2018
- Descendant · cites it directly · 1 of its ownK213407 UltiCare Disposable Pen NeedlesUltimed Incorporated · 2021
- Descendant · 2 generations on · 0 of its ownK260739 Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK230635 Pen NeedleJiangsu Caina Medical Co.,Ltd · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K171982Droplet Pen NeedleHtl-Strefa S.A · 2018 · cites it directly3descendants
- K182320BD Contoured Base Pen NeedleBecton, Dickinson and Company · 2018 · cites it directly2descendants
- K213407UltiCare Disposable Pen NeedlesUltimed Incorporated · 2021 · cites it directly1descendant
- K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026 · 2 generations on0descendants
- K230635Pen NeedleJiangsu Caina Medical Co.,Ltd · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −3 | K100005 | BD Pen Needle | Becton, Dickinson and Co. | 2010 | — |
| −2 | K123300 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| −1 | K131358 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| 0 (this device) | K162516 | BD Pen Needle | Becton, Dickinson and Company | 2016 | — |
| +1 | K171982 | Droplet Pen Needle | Htl-Strefa S.A | 2018 | — |
| +1 | K182320 | BD Contoured Base Pen Needle | Becton, Dickinson and Company | 2018 | — |
| +1 | K213407 | UltiCare Disposable Pen Needles | Ultimed Incorporated | 2021 | — |
| +2 | K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026 | — |
| +2 | K230635 | Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K051899 | BD Pen NeedleSummary page 4…Product Code: FMI (hypodermic single lumen needle) Legally marketed predicate devices to which substantial equivalence is being claimed: K051899 and K131358: BD Pen Needle Reference Device: K110703: BD AutoShield™ Duo Pen Needle Device Description: The BD Pen Needle is des… | 2005 |
| * | K131358 | BD Pen NeedleSummary page 4…Product Code: FMI (hypodermic single lumen needle) Legally marketed predicate devices to which substantial equivalence is being claimed: K051899 and K131358: BD Pen Needle Reference Device: K110703: BD AutoShield™ Duo Pen Needle Device Description: The BD Pen Needle is designed for us… | 2013 |
| † | K110703 | BD Autoshield Duo Pen Needle | 2011 |
What descends from it? (10)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2021 | Class II | Z-1933-2021 | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
| Oct 23, 2020 | Class II | Z-0508-2021 | Under Investigation by firm | Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171982 (Htl-Strefa S.A, 2018) has gone furthest, with 3 descendants of its own.
- 13 other devices also cite its predicate K051899.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 devices for the subcutaneous injection of drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162516: 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/K162516
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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