510(k) · Cleared
ClearedDroplet Pen Needle 34G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Htl-Strefa S.A · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 21, 2020 as substantially equivalent to K140516 (Kofu Factory of Terumo Corp., 2014) after a 263-day review. Its family tree reaches back 4 generations to 2005. 2 later devices descend from it.
- Decided
- Apr 21, 2020
- Review
- 263 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051899 (2005). 7 ancestors in all, the oldest K955235 (1996). 2 later devices descend from it, 2 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 backK140516 Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014
- This deviceK192082 Droplet Pen Needle 34GHtl-Strefa S.A · 2020
- Descendant · cites it directly · 0 of its ownK203792 Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED…Pikdare Spa · 2023
- Descendant · cites it directly · 0 of its ownK202340 Droplet Pen Needle 30G & 33GHtl-Strefa S.A · 2020
Most influential descendants
Showing 2 of 2 · See allView 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 | K140516 | Terumo Pen Injector Needle 34 | Kofu Factory of Terumo Corp. | 2014 | — |
| 0 (this device) | K192082 | Droplet Pen Needle 34G | Htl-Strefa S.A | 2020 | — |
| +1 | K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | Pikdare Spa | 2023 | — |
| +1 | 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 | 1 | 0 |
| 2023 | 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? (1)
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.
What descends from it? (2)
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 15 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K203792 (Pikdare Spa, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140516.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 DROPLET® PEN NEEDLE 34G 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/K192082 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192082: Droplet Pen Needle 34G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192082
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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