510(k) · Cleared
ClearedHumapen and Humapen Ergo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eli Lilly and Co. · FMF Syringe, Piston
Cleared on Sep 25, 1998 after a 44-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 25, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK982842 Humapen and Humapen ErgoEli Lilly and Co. · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K982842 | Humapen and Humapen Ergo | Eli Lilly and Co. | 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 | — |
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 16.2 · 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? (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 |
|---|---|---|---|
| * | — | B-D Pen Named without a submission number |
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?
- 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 HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector
designed for use by diabetics for the self-injection of a desired dose of insulin. The pen-
injector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use,
detachable and disposable pen needle (supplied separately). The pen-injector allows the
user to dial the desired dose one unit at a time up to 60 units.
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/K982842 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982842: Humapen and Humapen Ergo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982842
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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