510(k) · Cleared
ClearedTerumo Pen Injector Needle 34
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kofu Factory of Terumo Corp. · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 5, 2014 as substantially equivalent to K123300 (Becton, Dickinson & CO, 2013) and 1 other predicate after a 158-day review. Its family tree reaches back 3 generations to 2005. 4 later devices descend from it.
- Decided
- Aug 5, 2014
- Review
- 158 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K051899 (2005). 6 ancestors in all, the oldest K955235 (1996). 4 later devices descend from it, 2 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 deviceK140516 Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014
- Descendant · cites it directly · 2 of its ownK192082 Droplet Pen Needle 34GHtl-Strefa S.A · 2020
- Descendant · cites it directly · 0 of its ownK250700 Pen Injector Needle 32.5Terumo Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK203792 Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED…Pikdare Spa · 2023
- Descendant · 2 generations on · 0 of its ownK202340 Droplet Pen Needle 30G & 33GHtl-Strefa S.A · 2020
Most influential descendants
Showing 4 of 4 · See all- K192082Droplet Pen Needle 34GHtl-Strefa S.A · 2020 · cites it directly2descendants
- K250700Pen Injector Needle 32.5Terumo Corporation · 2025 · cites it directly0descendants
- K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa · 2023 · 2 generations on0descendants
- K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A · 2020 · 2 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) | K140516 | Terumo Pen Injector Needle 34 | Kofu Factory of Terumo Corp. | 2014 | — |
| +1 | K192082 | Droplet Pen Needle 34G | Htl-Strefa S.A | 2020 | — |
| +1 | K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025 | — |
| +2 | K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | Pikdare Spa | 2023 | — |
| +2 | K202340 | Droplet Pen Needle 30G & 33G | Htl-Strefa S.A | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K123300 | BD Pen NeedleSummary page 7…sification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed is/are: 1. K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New… | 2013 |
| * | K052561 | Terumo Micro Tapered Pen NeedleSummary page 7…1. K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey. 2. K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan. D. REASON FOR 510(K) SU… | 2005 |
What descends from it? (4)
2 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K192082 (Htl-Strefa S.A, 2020) has gone furthest, with 2 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. 2014, 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?
The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140516: Terumo Pen Injector Needle 34.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140516
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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