510(k) · Cleared
ClearedDisentronic Penfine 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 Dec 29, 1999 as substantially equivalent to K982399 (Disetronic Medical Systems, 1998) after a 16-day review. Its family tree reaches back 2 generations to 1997. 17 later devices descend from it.
- Decided
- Dec 29, 1999
- Review
- 16 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970737 (1997). 3 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 1 generation backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- This deviceK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- Descendant · cites it directly · 13 of its ownK102108 Clickfine Pen NeedleYpsomed AG · 2010
- Descendant · 2 generations on · 9 of its ownK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- Descendant · 3 generations on · 8 of its ownK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- Descendant · 4 generations on · 7 of its ownK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- Descendant · 5 generations on · 4 of its ownK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K102108Clickfine Pen NeedleYpsomed AG · 2010 · cites it directly13descendants
- K110312Clickfine Autoprotect Pen NeedleYpsomed AG · 2012 · 2 generations on9descendants
- K131123Clickfine Autoprotect Pen NeedleYpsomed AG · 2013 · 3 generations on8descendants
- K152514Clickfine AutoProtect Pen NeedleYpsomed AG · 2015 · 4 generations on7descendants
- K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −1 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| 0 (this device) | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| +1 | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| +2 | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| +3 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| +4 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| +5 | K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 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? (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 |
|---|---|---|---|
| * | K982399 | Disetronic Penfine Injection Pen NeedleSummary page 1…rently Marketed Devices The 6 mm Disetronic Penfine® Injection Pen Needles are substantially equivalent to the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles (K982399). 8.5 Device Description The 6 mm Disetronic Penfine® injection Pen Needies are the same sterile, non-pyrogenic, single use nee… | 1998 |
What descends from it? (17)
See all 172 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 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102108 (Ypsomed AG, 2010) has gone furthest, with 13 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® Injection Pen Needles are intended for the hypodermic injection of fluids 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/K994197 · printed Nov 3, 2026
Cite this page
510(k) Report. “K994197: Disentronic Penfine Injection Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K994197
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