510(k) · Cleared
ClearedWell-life TM Pen Needles, Well-life TM Safety Pen Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Med Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on May 25, 2022 as substantially equivalent to K113186 (Shina Corp., 2012) and 1 other predicate after a 439-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- May 25, 2022
- Review
- 439 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951254 (1995). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 4 generations backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
- 3 generations backK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
- 2 generations backK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
- 1 generation backK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
- This deviceK210748 Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260855 Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951254 | Safetyglide Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 4 |
| −4 | K050106 | Novofine Autocover 30G X 8MM | Novo Nordisk, Inc. | 2005 | — |
| −3 | K062500 | Flexpen Needle | Novo Nordisk, Inc. | 2006 | — |
| −2 | K090111 | Flexpen Needle | Novo Nordisk, Inc. | 2010 | — |
| −1 | K113186 | Sterile Insulin Pen Needle | Shina Corp. | 2012 | — |
| 0 (this device) | K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | 2022 | — |
| +1 | K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2018 | 1 | 0 |
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 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? (2)
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 |
|---|---|---|---|
| * | K113186 | Sterile Insulin Pen NeedleSummary page 4…S3310 S3404 S3405 S3406 S3408 3. The legally marketed device to which we are claiming equivalence Predicate Device #1: K113186, ShinaPen / SHINA CORPORATION Predicate Device #2: K172095, Autokeeper / MedExel Co., Ltd. 4. Device description The… | 2012 |
| * | K172095 | AutokeeperSummary page 4…S3408 3. The legally marketed device to which we are claiming equivalence Predicate Device #1: K113186, ShinaPen / SHINA CORPORATION Predicate Device #2: K172095, Autokeeper / MedExel Co., Ltd. 4. Device description The Well-life™ Safety Pen Needles and Well-life™ Pen Needles are sin… | 2018 |
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 |
|---|---|---|---|
| K260855 | Profoject™ Safety Pen Needles | 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 27 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K260855 (CMT Health PTE., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113186.
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?
This device is intended for use with pen injector devices for the subcutaneous injection of insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210748
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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