510(k) · Cleared
ClearedInsupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pikdare Spa · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 20, 2023 as substantially equivalent to K192082 (Htl-Strefa S.A, 2020) after a 753-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Jan 20, 2023
- Review
- 753 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K051899 (2005). 8 ancestors in all, the oldest K955235 (1996). No later device cites it as a predicate yet.
- 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 backK140516 Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014
- 1 generation backK192082 Droplet Pen Needle 34GHtl-Strefa S.A · 2020
- This deviceK203792 Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED…Pikdare Spa · 2023
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 | K140516 | Terumo Pen Injector Needle 34 | Kofu Factory of Terumo Corp. | 2014 | — |
| −1 | K192082 | Droplet Pen Needle 34G | Htl-Strefa S.A | 2020 | — |
| 0 (this device) | K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | Pikdare Spa | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192082 | Droplet Pen Needle 34GSummary page 5…ce device Artsana SpA Insupen pen needle K051783 Primary Device HTL-STREFA S.A. DROPLET® PEN K192082 NEEDLE 34G In 2019 Artsana SpA has moved the proprietary of its 510K… | 2020 |
| † | K051783 | Artsana Pen Needles, Artsana Injection Needles | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K192082.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Sterile, single use needles 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/K203792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203792: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED 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/K203792
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