510(k) · Cleared
Recalled · Class II · 2020Sol-Care Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sol-Millennium Medical · FMI Needle, Hypodermic, Single Lumen
Cleared on May 8, 2013 as substantially equivalent to K010188 (Bd Medical Systems, 2001) after a 159-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- May 8, 2013
- Review
- 159 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010188 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010188 BD Eclipse Hypodermic NeedleBd Medical Systems · 2001
- This deviceK123684 Sol-Care Safety NeedleSol-Millennium Medical · 2013
- Descendant · cites it directly · 0 of its ownK222271 Verisafe Safety sterile needlesPromisemed Hangzhou Meditech Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK152183 EXELINT SecureTouch Safety Hypodermic NeedleExelint International, Co. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010188 | BD Eclipse Hypodermic Needle | Bd Medical Systems | 2001 | — |
| 0 (this device) | K123684 | Sol-Care Safety Needle | Sol-Millennium Medical | 2013 | — |
| +1 | K222271 | Verisafe Safety sterile needles | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| +1 | K152183 | EXELINT SecureTouch Safety Hypodermic Needle | Exelint International, Co. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K010188 | BD Eclipse Hypodermic NeedleSummary page 1…the addition of asafety feature) C. Predicate Device: BD Eclipse Hypodermic Needle Predicate 510(~k) #: 1(010188 Predicate product code:. EMI D. Device Description The Sal-Care Safet… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2020 | Class II | Z-1455-2020 | Under Investigation by firm | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in… |
| Jan 15, 2020 | Class II | Z-1454-2020 | Under Investigation by firm | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Sol-Care Safety Hypodermic Needle is used in conjunction with a standard syringe.
This device is used for aspiration and administration of medication.
The Sol-Care Safety Hypodermic Needle safety mechanism covers the needle after use.
In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123684: Sol-Care Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123684
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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