510(k) · Cleared
ClearedFine Ject Insulin Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Twobiens Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 10, 2012 as substantially equivalent to K080904 (Feel Tech, 2008) and 1 other predicate after a 151-day review. Its family tree reaches back 3 generations to 1997. 21 later devices descend from it.
- Decided
- Jan 10, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973899 (1997). 5 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 2 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 1 generation backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- This deviceK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- Descendant · cites it directly · 20 of its ownK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- Descendant · 2 generations on · 18 of its ownK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- Descendant · 3 generations on · 9 of its ownK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK181069 Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK152824 Medt Pen NeedleShandong Caremed Medical Products Co., Ltd. · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K120690Insulin Pen NeedleTiger Medical Products, Ltd. · 2012 · cites it directly20descendants
- K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014 · 2 generations on18descendants
- K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017 · 3 generations on9descendants
- K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 3 generations on3descendants
- K152824Medt Pen NeedleShandong Caremed Medical Products Co., Ltd. · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −2 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −1 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| 0 (this device) | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| +1 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| +2 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| +3 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 | — |
| +3 | K181069 | Disposable Insulin Pen Needle | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| +3 | K152824 | Medt Pen Needle | Shandong Caremed Medical Products Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K080904 | Feel-Fine Insulin Pen NeedleSummary page 2…evice and is safe and effective when used as intended. G. The legally marketed devices to which we are claiming equivalence: Feel Fine Insulin Pen Needle. K080904 BD 320 x 4mim Pen Needle :KI 00005 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2008 |
| * | K100005 | BD Pen Needle | 2010 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120690 | Insulin Pen Needle | 2012 | 20 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120690 (Tiger Medical Products, Ltd., 2012) has gone furthest, with 20 descendants of its own.
- 7 other devices also cite its predicate K080904.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
These disposable sterile Insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112332: Fine Ject 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/K112332
Report an extraction error
Are you the manufacturer?
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