510(k) · Cleared
ClearedPen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hh Global Technology, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 6, 2026 as substantially equivalent to K220129 (Promisemed Hangzhou Meditech Co., Ltd., 2022) after a 118-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it.
- Decided
- Jan 6, 2026
- Review
- 118 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051899 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 3 generations backK060007 BD Autoshield Pen NeedleBecton, Dickinson & CO · 2006 · Recalled
- 2 generations backK163578 EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 2018
- 1 generation backK220129 Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022
- This deviceK252886 Pen NeedleHh Global Technology, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK262427 Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB…Hh Global Technology, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…Hh Global Technology, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −3 | K060007 | BD Autoshield Pen Needle | Becton, Dickinson & CO | 2006 | 1 |
| −2 | K163578 | EasyTouch Safety Pen Needle | Mhc Medical Products, LLC | 2018 | — |
| −1 | K220129 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022 | — |
| 0 (this device) | K252886 | Pen Needle | Hh Global Technology, Inc. | 2026 | — |
| +1 | 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 | 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 K260933 Safety Sterile Hypodermic Needles (NR-S1816R…score 13.9 · 8 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 |
|---|---|---|---|
| * | K220129 | Promisemed X-Safety Pen NeedleSummary page 5…CFR 880.5570 Regulatory Class: Class II Product code: FMI Review Panel: General Hospital III Predicate and Reference Devices Predicate Device: 510(k) Number: K220129 Product Code: FMI Classification: 21 CFR 880.5570 Trade Name: Promisemed X-Safety Pen Needle Manufacturer: Promis… | 2022 |
| † | K230635 | Pen Needle | 2023 |
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 |
|---|---|---|---|
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety… | 2026 | 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 21 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K262427 (Hh Global Technology, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K220129.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252886: Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252886
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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