510(k) · Cleared
ClearedDisetronic Penfine Insulin Injection Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disetronic Medical Systems · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 20, 2001 as substantially equivalent to K982399 (Disetronic Medical Systems, 1998) and 1 other predicate after a 6-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Nov 20, 2001
- Review
- 6 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K970737 (1997). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 2 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 1 generation backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- This deviceK013782 Disetronic Penfine Insulin Injection Pen NeedleDisetronic Medical Systems · 2001
- Descendant · cites it directly · 3 of its ownK100436 Clickfine Pen NeedleYpsomed AG · 2010
- Descendant · 2 generations on · 2 of its ownK122969 Clickfine Pen NeedleP/L Biomedical · 2012
- Descendant · 3 generations on · 1 of its ownK131125 Clickfine Pen NeedleYpsomed AG · 2013
- Descendant · 4 generations on · 0 of its ownK150662 Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names…Ypsomed AG · 2015
Most influential descendants
Showing 4 of 4 · See all- K100436Clickfine Pen NeedleYpsomed AG · 2010 · cites it directly3descendants
- K122969Clickfine Pen NeedleP/L Biomedical · 2012 · 2 generations on2descendants
- K131125Clickfine Pen NeedleYpsomed AG · 2013 · 3 generations on1descendant
- K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −2 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −1 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| 0 (this device) | K013782 | Disetronic Penfine Insulin Injection Pen Needle | Disetronic Medical Systems | 2001 | — |
| +1 | K100436 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| +2 | K122969 | Clickfine Pen Needle | P/L Biomedical | 2012 | — |
| +3 | K131125 | Clickfine Pen Needle | Ypsomed AG | 2013 | — |
| +4 | K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | Ypsomed AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982399 | Disetronic Penfine Injection Pen NeedleSummary page 1…Currently Marketed Devices The Disetronic Penfine® Insulin Injection Pen Needles are substantially equivalent to the current Disetronic Penfine® Injection Pen Needles (K982399, K994197, K992399). Device Description The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, non- pyrogen… | 1998 |
| * | K994197 | Disentronic Penfine Injection Pen NeedleSummary page 1…y Marketed Devices The Disetronic Penfine® Insulin Injection Pen Needles are substantially equivalent to the current Disetronic Penfine® Injection Pen Needles (K982399, K994197, K992399). Device Description The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, non- pyrogenic, singl… | 1999 |
| Kept off the family tree | K992399 | FDA’s K992399 is Additional Ims Assays for the Bayer Advia Ims System Our OCR of the scanned summary read K992399, FDA’s number for Additional Ims Assays for the Bayer Advia Ims System (Bayer Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Disetronic Penfine® Injection Pen Needles”. Kept off the family tree. Summary page 1…d Devices The Disetronic Penfine® Insulin Injection Pen Needles are substantially equivalent to the current Disetronic Penfine® Injection Pen Needles (K982399, K994197, K992399). Device Description The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, non- pyrogenic, single use nee… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100436 | Clickfine Pen Needle | 2010 | 3 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K100436 (Ypsomed AG, 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K982399.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013782: Disetronic Penfine Insulin Injection 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/K013782
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026