510(k) · Cleared
ClearedSol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sol-Millennium Medical, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 3, 2018 as substantially equivalent to K172763 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) after a 117-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Dec 3, 2018
- Review
- 117 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972404 (1997). 4 ancestors in all, the oldest K965202 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 2 generations backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- 1 generation backK172763 Blood Collecting Needle, Safety Blood Collecting Needle, Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- This deviceK182146 Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection…Sol-Millennium Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK201009 CHIRAVAC Blood Collection NeedlesChirana T. Injecta · 2021
Most influential descendants
Showing 1 of 1 · See all- K201009CHIRAVAC Blood Collection NeedlesChirana T. Injecta · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −2 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| −1 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| 0 (this device) | K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles… | Sol-Millennium Medical, Inc. | 2018 | — |
| +1 | K201009 | CHIRAVAC Blood Collection Needles | Chirana T. Injecta | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Summary page 4…Regulatory Class: II Product Code: FMI Reference: K172763 Sol-Millennium Medical C. Device Description The proposed devices are blood collection devices form a c… | 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 |
|---|---|---|---|
| K201009 | CHIRAVAC Blood Collection Needles | 2021 | 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 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K201009 (Chirana T. Injecta, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K172763.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood…
Read the full statement (118 words)
The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182146: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182146
Report an extraction error
Are you the manufacturer?
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