510(k) · Cleared
ClearedOne.Click Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 9, 2004 as substantially equivalent to K973899 (Owen Mumford USA, Inc., 1997) after an 89-day review. Its family tree reaches back 1 generation to 1997. 43 later devices descend from it.
- Decided
- Feb 9, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973899 (1997). 43 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- This deviceK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- Descendant · cites it directly · 30 of its ownK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- Descendant · 2 generations on · 21 of its ownK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- Descendant · 3 generations on · 20 of its ownK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- Descendant · 4 generations on · 18 of its ownK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- Descendant · cites it directly · 11 of its ownK063466 Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K080904Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · cites it directly30descendants
- K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012 · 2 generations on21descendants
- K120690Insulin Pen NeedleTiger Medical Products, Ltd. · 2012 · 3 generations on20descendants
- K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014 · 4 generations on18descendants
- K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| 0 (this device) | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| +1 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| +2 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| +3 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| +4 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| +1 | K063466 | Top Fine | Daejin Tech Medical Manufacturing Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 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 |
|---|---|---|---|
| * | K973899 | Unifine PentipsSummary page 1…egulations, Title 21 § 880.5570 Hypodermic Single Lumen Needle PRE)ICATE DEVICE: Owen Mumford, Inc. Unifine® Pentip® (K973899) DESCRIPTION: The one.click needle is a double-ended needle consisting of a tribeve… | 1997 |
What descends from it? (43)
See all 432 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?
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 one.click needle is a sterile, single-packed, disposable hypodermic single lumen needle designed for use with a multidose pen injection device, the one.click auto-injector, for the subcutaneous injection of fluid drug products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033575: One.Click Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033575
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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