510(k) · Cleared
ClearedEasydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandstone Medical (Suzhou), Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Mar 25, 2026 as substantially equivalent to K193422 (Sandstone Medical (Suzhou), Inc., 2021) after a 194-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Mar 25, 2026
- Review
- 194 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K973899 (1997). 15 ancestors in all, the oldest K951254 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 7 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 6 generations backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
- 5 generations backK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
- 4 generations backK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
- 3 generations backK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
- 2 generations backK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
- 1 generation backK193422 Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021
- This deviceK252908 Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip…Sandstone Medical (Suzhou), Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −7 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −6 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| −5 | K112332 | Fine Ject Insulin Pen Needle | Twobiens Co., Ltd. | 2012 | — |
| −4 | K120690 | Insulin Pen Needle | Tiger Medical Products, Ltd. | 2012 | — |
| −3 | K133059 | Insulin Pen Needle | Wenzhou Beipu Science & Technology Co., Ltd. | 2014 | — |
| −2 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 | — |
| −1 | K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | Sandstone Medical (Suzhou), Inc. | 2021 | — |
| 0 (this device) | K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro… | Sandstone Medical (Suzhou), Inc. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K193422 | Easydrip Pen Needle, Easydrip Plus Pen NeedleSummary page 5…Single Lumen / FMI Submission type Special 510(K) 3. Predicate Device Sandstone Medical (Suzhou) Inc., Easydrip Pen Needle; Easydrip Plus Pen Needle, under K193422. 4. Device Description Easydrip Pen Needles are single-use, sterile, and non-pyrogenic medical device designed to be used wit… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 15 ancestors have 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?
The pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252908: Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro 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/K252908
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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