510(k) · Cleared
ClearedDroplet Pen Needle
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 Mar 21, 2018 as substantially equivalent to K162516 (Becton, Dickinson and Company, 2016) and 1 other predicate after a 264-day review. Its family tree reaches back 5 generations to 2005. 3 later devices descend from it.
- Decided
- Mar 21, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K051899 (2005). 7 ancestors in all, the oldest K031200 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 4 generations backK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
- 3 generations backK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
- 2 generations backK131358 BD Pen NeedleBecton, Dickinson & CO · 2013
- 1 generation backK162516 BD Pen NeedleBecton, Dickinson and Company · 2016 · Recalled
- This deviceK171982 Droplet Pen NeedleHtl-Strefa S.A · 2018
- Descendant · cites it directly · 0 of its ownK260739 Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230635 Pen NeedleJiangsu Caina Medical Co.,Ltd · 2023
- Descendant · cites it directly · 0 of its ownK192464 Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd. · 2026 · cites it directly0descendants
- K230635Pen NeedleJiangsu Caina Medical Co.,Ltd · 2023 · cites it directly0descendants
- K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −4 | K100005 | BD Pen Needle | Becton, Dickinson and Co. | 2010 | — |
| −3 | K123300 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| −2 | K131358 | BD Pen Needle | Becton, Dickinson & CO | 2013 | — |
| −1 | K162516 | BD Pen Needle | Becton, Dickinson and Company | 2016 | 2 |
| 0 (this device) | K171982 | Droplet Pen Needle | Htl-Strefa S.A | 2018 | — |
| +1 | K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026 | — |
| +1 | K230635 | Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2023 | — |
| +1 | K192464 | Injection Pen Needle | Gangan Medical Technology Jiangsu Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K162516 | BD Pen NeedleSummary page 5…is claimed is: Manufacturer Trade Name 510(k) Number Becton Dickson & Co. BD Pen Needle K162516 Secondary Predicate Device Manufacturer Name Trade Name 5… | 2016 |
| * | K143437 | Droplet Pen NeedlesSummary page 5…redicate Device Manufacturer Name Trade Name 510(k) Number HTL-Strefa S.A. Droplet® Pen Needle K143437 The secondary predicate device cleared under K143437 has been included in this submission to cover all gages and lengths of the… | 2015 |
What descends from it? (3)
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K260739 (CMT Health PTE., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K162516.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Droplet® Pen Needles are 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/K171982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171982: Droplet 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/K171982
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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