510(k) · Cleared
ClearedPromisemed X-Safety 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 Sep 19, 2022 as substantially equivalent to K163578 (Mhc Medical Products, LLC, 2018) after a 244-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Sep 19, 2022
- Review
- 244 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051899 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 2 generations backK060007 BD Autoshield Pen NeedleBecton, Dickinson & CO · 2006 · Recalled
- 1 generation backK163578 EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 2018
- This deviceK220129 Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK252886 Pen NeedleHh Global Technology, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261719 Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK262427 Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB…Hh Global Technology, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K252886Pen NeedleHh Global Technology, Inc. · 2026 · cites it directly1descendant
- K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026 · cites it directly0descendants
- K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…Hh Global Technology, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −2 | K060007 | BD Autoshield Pen Needle | Becton, Dickinson & CO | 2006 | 1 |
| −1 | K163578 | EasyTouch Safety Pen Needle | Mhc Medical Products, LLC | 2018 | — |
| 0 (this device) | K220129 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022 | — |
| +1 | K252886 | Pen Needle | Hh Global Technology, Inc. | 2026 | — |
| +1 | K261719 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
| +2 | K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type… | Hh Global Technology, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K163578 | EasyTouch Safety Pen NeedleSummary page 4…Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI 4 Identification of Predicate Device(s) K163578: EasyTouch Safety Pen Needle X-Safety Pen Needle K220129… | 2018 |
What descends from it? (3)
2 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 17 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K252886 (Hh Global Technology, Inc., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 X-safety pen needle is intended for use with needle based injector for the injection of drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220129: Promisemed X-Safety 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/K220129
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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