510(k) · Cleared
ClearedPromisemed 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 Jul 21, 2021 as substantially equivalent to K161950 (Promisemed Hangzhou Meditech Co., Ltd., 2017) after a 191-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Jul 21, 2021
- Review
- 191 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K973899 (1997). 14 ancestors in all, the oldest K951254 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 6 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 5 generations backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- 4 generations backK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- 3 generations backK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- 2 generations backK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- 1 generation backK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
- This deviceK210059 Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK222739 Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −6 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −5 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| −4 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| −3 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| −2 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| −1 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 | — |
| 0 (this device) | K210059 | Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +1 | K222739 | Disposable Insulin Pen Needle | Hantech Medical Device Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleSummary page 4…Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI 4 Identification of Predicate Device(s) K161950: Verifine Common Type Insulin Pen Needle 1… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222739 | Disposable Insulin Pen Needle | 2023 | 0 |
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 24 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K222739 (Hantech Medical Device Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K161950.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Promisemed Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
It is sterile and for single use only. It is suitable for all age groups including neonate, infant, children and adult, and can be used by the patient at home or healthcare professionals at medical/health care centers.
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/K210059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210059: Promisemed 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/K210059
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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