510(k) · Cleared
ClearedPen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
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 Aug 10, 2026 as substantially equivalent to K252886 (Hh Global Technology, Inc., 2026) after a 25-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Aug 10, 2026
- Review
- 25 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K051899 (2005). No later device cites it as a predicate yet.
- Root · 5 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
- 4 generations backK060007 BD Autoshield Pen NeedleBecton, Dickinson & CO · 2006 · Recalled
- 3 generations backK163578 EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 2018
- 2 generations backK220129 Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022
- 1 generation backK252886 Pen NeedleHh Global Technology, Inc. · 2026
- This deviceK262427 Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB…Hh Global Technology, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K051899 | BD Pen Needle | Becton, Dickinson & CO | 2005 | — |
| −4 | K060007 | BD Autoshield Pen Needle | Becton, Dickinson & CO | 2006 | 1 |
| −3 | K163578 | EasyTouch Safety Pen Needle | Mhc Medical Products, LLC | 2018 | — |
| −2 | K220129 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022 | — |
| −1 | K252886 | Pen Needle | Hh Global Technology, Inc. | 2026 | — |
| 0 (this device) | K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type… | Hh Global Technology, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K252886 | Pen NeedleSummary page 5…le Regulation Number: 21 CFR 880.5570 Regulatory Class: Class II Product code: FMI Review Panel: General Hospital III Predicate Device Predicate Device: 510(k) Number: K252886 Product Code: FMI Classification: 21 CFR 880.5570 Trade Name: Pen Needle (Ordinary Type I, Ordinary Type VIA, Ordinary Type VIB,… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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 3.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
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/K262427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262427: Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262427
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026