510(k) · Cleared
ClearedCommon Type Insulin Pen Needle, Safety Type Insulin Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on May 11, 2017 as substantially equivalent to K133059 (Wenzhou Beipu Science & Technology Co., Ltd., 2014) and 1 other predicate after a 300-day review. Its family tree reaches back 6 generations to 1997. 9 later devices descend from it.
- Decided
- May 11, 2017
- Review
- 300 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K973899 (1997). 13 ancestors in all, the oldest K951254 (1995). 9 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 5 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 4 generations backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- 3 generations backK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- 2 generations backK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- 1 generation backK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- This deviceK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK210059 Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK193422 Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021
- Descendant · cites it directly · 1 of its ownK191853 Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK252908 Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip…Sandstone Medical (Suzhou), Inc. · 2026
- Descendant · cites it directly · 0 of its ownK242632 Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021 · cites it directly1descendant
- K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021 · cites it directly1descendant
- K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2019 · cites it directly1descendant
- K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc. · 2026 · 2 generations on0descendants
- K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −5 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −4 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| −3 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| −2 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| −1 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| 0 (this device) | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 | — |
| +1 | K210059 | Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +1 | K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | Sandstone Medical (Suzhou), Inc. | 2021 | — |
| +1 | K191853 | Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| +2 | K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro… | Sandstone Medical (Suzhou), Inc. | 2026 | — |
| +1 | K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 3 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K133059 | Insulin Pen NeedleSummary page 5…edle Version:A/0 Trade Name Insulin Pen Needle 510(k) Number K133059 Product Code FMI Manufacturer Wenzhou Beipo Science & Technology Co., Ltd… | 2014 |
| * | K151311 | Safe Block Pen NeedleSummary page 5…MI Manufacturer Wenzhou Beipo Science & Technology Co., Ltd Trade Name Safe Block Pen Needle 510(k) Number K151311 Product Code FMI Manufacturer Artsana S.p.A Unit Production N°30, Via Saldarini Catelli 6… | 2016 |
| † | K152410 | Top Fine Pen Needle | 2016 |
What descends from it? (9)
6 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?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K210059 (Promisemed Hangzhou Meditech Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K133059.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Additionally, after withdrawal of the Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161950: Common Type Insulin Pen Needle, Safety Type 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/K161950
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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