510(k) · Cleared
ClearedDisetronic Pen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disetronic Medical Systems · FMF Syringe, Piston
Cleared on Oct 19, 1998 as substantially equivalent to K942159 (Novo Nordisk Pharmaceuticals, Inc., 1995) and 2 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 19, 1998
- Review
- 55 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K905693 (1991). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 1 generation backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- This deviceK982966 Disetronic PenDisetronic Medical Systems · 1998
- Descendant · cites it directly · 2 of its ownK070100 Haselmeier PenHaselmeier Sarl · 2007
- Descendant · cites it directly · 0 of its ownK083457 TactipenHaselmeier GmbH · 2009
- Descendant · 2 generations on · 0 of its ownK082616 Haselmeier Pen 8Haselmeier GmbH · 2008
- Descendant · cites it directly · 0 of its ownK993666 Disetronic Pen P100Disetronic Medical Systems · 1999
Most influential descendants
Showing 4 of 4 · See all- K070100Haselmeier PenHaselmeier Sarl · 2007 · cites it directly2descendants
- K083457TactipenHaselmeier GmbH · 2009 · cites it directly0descendants
- K082616Haselmeier Pen 8Haselmeier GmbH · 2008 · 2 generations on0descendants
- K993666Disetronic Pen P100Disetronic Medical Systems · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −1 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| 0 (this device) | K982966 | Disetronic Pen | Disetronic Medical Systems | 1998 | — |
| +1 | K070100 | Haselmeier Pen | Haselmeier Sarl | 2007 | — |
| +1 | K083457 | Tactipen | Haselmeier GmbH | 2009 | — |
| +2 | K082616 | Haselmeier Pen 8 | Haselmeier GmbH | 2008 | — |
| +1 | K993666 | Disetronic Pen P100 | Disetronic Medical Systems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K942159 | Novopen 1.5Summary page 1…tion Pen Ciassimcalion Name. Fision Synnge Substantiai Equivaience: Tne Disetronic injection Pen product iine is substantiaily equivaient to the NovoPen Injection Pen (K942159), the B-D Injection Pen (K941567) the sta;ndard Piston Syringe {B-D Syringe - iast submission K354064) and the Disetronic H-Tron… | 1995 |
| Kept off the family tree | K941567 | FDA’s K941567 is Diathermy Device-Microfocus Our OCR of the scanned summary read K941567, FDA’s number for Diathermy Device-Microfocus (Cheung Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “B-D Injection Pen”. Kept off the family tree. Summary page 1…ion Synnge Substantiai Equivaience: Tne Disetronic injection Pen product iine is substantiaily equivaient to the NovoPen Injection Pen (K942159), the B-D Injection Pen (K941567) the sta;ndard Piston Syringe {B-D Syringe - iast submission K354064) and the Disetronic H-Tron pius insuiin Infusion Pump (K9730… | 1996 |
| * | K954064 | Becton Dickinson Syringse Our OCR of the scanned summary read K354064, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. | 1995 |
| * | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion PumpSummary page 1…Pen (K942159), the B-D Injection Pen (K941567) the sta;ndard Piston Syringe {B-D Syringe - iast submission K354064) and the Disetronic H-Tron pius insuiin Infusion Pump (K973044). 5 The Disetronic injection Pen is a reusabie devices that provides a method of accurately injecting a selected dose of insuli… | 1997 |
What descends from it? (4)
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 7 years and passes through 1 company; a new generation was cleared every 6.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K070100 (Haselmeier Sarl, 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The device is indicated for the injection of insulin into the body.
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/K982966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982966: Disetronic Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982966
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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