510(k) · Cleared
ClearedUnifine Pentips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owen Mumford USA, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 4, 1997 after a 51-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.
- Decided
- Dec 4, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 2 citing it directly.
- This deviceK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- Descendant · cites it directly · 43 of its ownK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- Descendant · 2 generations on · 30 of its ownK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- Descendant · 3 generations on · 21 of its ownK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- Descendant · 4 generations on · 20 of its ownK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- Descendant · 5 generations on · 18 of its ownK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K033575One.Click NeedleB.Braun Medical, Inc. · 2004 · cites it directly43descendants
- K080904Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · 2 generations on30descendants
- K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012 · 3 generations on21descendants
- K120690Insulin Pen NeedleTiger Medical Products, Ltd. · 2012 · 4 generations on20descendants
- K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| +1 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| +2 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| +3 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| +4 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| +5 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 5 | 0 |
| 2016 | 10 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Becton Dickinson Microfine Named without a submission number |
What descends from it? (47)
See all 472 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, K033575 (B.Braun Medical, Inc., 2004) has gone furthest, with 43 descendants of its own.
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 Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.
The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.
One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.
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/K973899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973899: Unifine Pentips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973899
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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