510(k) · Cleared
Recalled · Class II · 2014Owen Mumford 3ML Autopen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owen Mumford USA, Inc. · FMF Syringe, Piston
Cleared on Dec 21, 1998 as substantially equivalent to K895890 (Ulster Scientific, Inc., 1990) after a 42-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 1998
- Review
- 42 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895890 (1990). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK895890 AutopenUlster Scientific, Inc. · 1990
- This deviceK983974 Owen Mumford 3ML AutopenOwen Mumford USA, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK063151 Humapen Luxura HDEli Lilly and Co. · 2007
- Descendant · 2 generations on · 4 of its ownK100988 Humapen Luxura HDEli Lilly and Company · 2010
- Descendant · 3 generations on · 3 of its ownK142518 HumaPen LuxuraEli Lilly and Company · 2015
- Descendant · 4 generations on · 1 of its ownK160668 HumaPen SavvioEli Lilly and Company, Inc. · 2016
- Descendant · 5 generations on · 0 of its ownK250262 GO-PEN®Go-Pen Aps · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K063151Humapen Luxura HDEli Lilly and Co. · 2007 · cites it directly5descendants
- K100988Humapen Luxura HDEli Lilly and Company · 2010 · 2 generations on4descendants
- K142518HumaPen LuxuraEli Lilly and Company · 2015 · 3 generations on3descendants
- K160668HumaPen SavvioEli Lilly and Company, Inc. · 2016 · 4 generations on1descendant
- K250262GO-PEN®Go-Pen Aps · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895890 | Autopen | Ulster Scientific, Inc. | 1990 | — |
| 0 (this device) | K983974 | Owen Mumford 3ML Autopen | Owen Mumford USA, Inc. | 1998 | — |
| +1 | K063151 | Humapen Luxura HD | Eli Lilly and Co. | 2007 | — |
| +2 | K100988 | Humapen Luxura HD | Eli Lilly and Company | 2010 | — |
| +3 | K142518 | HumaPen Luxura | Eli Lilly and Company | 2015 | — |
| +4 | K160668 | HumaPen Savvio | Eli Lilly and Company, Inc. | 2016 | — |
| +5 | K250262 | GO-PEN® | Go-Pen Aps | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K895890 | AutopenSummary page 1…By: Robert E. Shaw Owen Mumford, Inc. 849 Pickens Industrial Dr. Suite 14 Marietta, GA 30062-3165 Device Name: Autopen® 3ml Substantial Equivalence: Autopen® 1.5ml K895890 Classification Name: Introducer, Syringe Piston DESCRIPTION: Autopen® is cylindrical in shape, approximately 165mm x 15mm inclu… | 1990 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2014 | Class II | Z-2082-2015 | Process control | The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K063151 (Eli Lilly and Co., 2007) has gone furthest, with 5 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 delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford 3ml Autopen is a non-sterile automatic subcutaneous injection device which uses a replaceable 3ml insulin cartridge held within the body of the device. An automatic drive system is used to displace the insulin from the cartridge through a sterile disposable needle.
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/K983974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983974: Owen Mumford 3ML Autopen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983974
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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