510(k) · Cleared
ClearedHaselmeier Pen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haselmeier Sarl · FMF Syringe, Piston
Cleared on Mar 21, 2007 as substantially equivalent to K060141 (Shl Medical, USA, 2006) and 2 other predicates after a 70-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 21, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K905693 (1991). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991 · Recalled
- 2 generations backK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
- 1 generation backK982966 Disetronic PenDisetronic Medical Systems · 1998
- This deviceK070100 Haselmeier PenHaselmeier Sarl · 2007
- Descendant · cites it directly · 0 of its ownK083457 TactipenHaselmeier GmbH · 2009
- Descendant · cites it directly · 0 of its ownK082616 Haselmeier Pen 8Haselmeier GmbH · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1991 | 1 |
| −2 | K973044 | Disetronic H-Tron Plus V 100 Insulin Infusion Pump | Disetronic Medical Systems | 1997 | 5 |
| −1 | K982966 | Disetronic Pen | Disetronic Medical Systems | 1998 | — |
| 0 (this device) | K070100 | Haselmeier Pen | Haselmeier Sarl | 2007 | — |
| +1 | K083457 | Tactipen | Haselmeier GmbH | 2009 | — |
| +1 | K082616 | Haselmeier Pen 8 | Haselmeier GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 16.2 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060141 | DAI-RSummary page 1…cate Device Manufacturer Product Name 510(k) No. SHL Medical, USA DAI-RTm Autoinjector K060141 Disetronic Medical System Disetronic Pen K982966 Eli Lilly and Company HumnaPen and… | 2006 |
| * | K982966 | Disetronic PenSummary page 1…510(k) No. SHL Medical, USA DAI-RTm Autoinjector K060141 Disetronic Medical System Disetronic Pen K982966 Eli Lilly and Company HumnaPen and HurnaPen Ergo K982842 Skri… | 1998 |
| * | K982842 | Humapen and Humapen ErgoSummary page 1…K060141 Disetronic Medical System Disetronic Pen K982966 Eli Lilly and Company HumnaPen and HurnaPen Ergo K982842 Skri elifl~l& 510(k) Premarket Noti… | 1998 |
What descends from it? (2)
2 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 16 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K083457 (Haselmeier GmbH, 2009) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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 Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070100 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070100: Haselmeier Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070100
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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