510(k) · Cleared
ClearedCareSens Pen Needle, Softip Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yidobio, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 7, 2016 as substantially equivalent to K063466 (Daejin Tech Medical Manufacturing Co., Ltd., 2007) after a 190-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 7, 2016
- Review
- 190 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973899 (1997). 7 ancestors in all, the oldest K955235 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
- 2 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
- 1 generation backK063466 Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007
- This deviceK160575 CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −2 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −1 | K063466 | Top Fine | Daejin Tech Medical Manufacturing Co., Ltd. | 2007 | — |
| 0 (this device) | K160575 | CareSens Pen Needle, Softip Pen Needle | Yidobio, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K063466 | Top FineSummary page 5…n exception to the brand name. 7. Predicate Device The legally marketed device(s) to which substantial equivalence is claimed is/are: ● K063466 TopFine® Insulin Pen, Manufactured by Daejin Tech Medical Manufacturing Co., Ltd., Korea Regulation Name:… | 2007 |
| † | K131358 | BD Pen Needle | 2013 |
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 19 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K063466.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160575: CareSens Pen Needle, Softip 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/K160575
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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