510(k) · Cleared
ClearedInsulin Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 20, 2023 as substantially equivalent to K202319 (Tianjin Huahong Technology Co., Ltd., 2021) after a 257-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Sep 20, 2023
- Review
- 257 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K973899 (1997). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 7 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 6 generations backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- 5 generations backK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- 4 generations backK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- 3 generations backK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- 2 generations backK181069 Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd. · 2018
- 1 generation backK202319 Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Tianjin Huahong Technology Co., Ltd. · 2021
- This deviceK230043 Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −7 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −6 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| −5 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| −4 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| −3 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| −2 | K181069 | Disposable Insulin Pen Needle | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| −1 | K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | Tianjin Huahong Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K230043 | Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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 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 |
|---|---|---|---|
| * | K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Summary page 5…Hospital Regulatory Class: II Product Code: FMI III. PREDICATE DEVICE Primary predicate device: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319) 4-2… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 9 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230043: Insulin Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230043
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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