510(k) · Cleared
Cleared0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sol-Millennium Medical, Inc. · MEG Syringe, Antistick
Cleared on Aug 19, 2016 as substantially equivalent to K092430 (Inviro Medical Devices, Inc., 2009) after a 28-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Aug 19, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941450 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
- 2 generations backK032780 Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003
- 1 generation backK092430 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock…Inviro Medical Devices, Inc. · 2009
- This deviceK162030 0.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941450 | Inviro Syringe | Dr. F. Ross Sharp, Ltd. | 1994 | — |
| −2 | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC | Inviro Medical | 2003 | — |
| −1 | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML… | Inviro Medical Devices, Inc. | 2009 | — |
| 0 (this device) | K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | 2016 | — |
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 MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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 |
|---|---|---|---|
| * | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…Summary page 4…ge Syringes received marketing clearance on September 4, 2009 under 510(k) # K092430. Predicate product code: MEG D. Device Description The 0.5ml Sol-Care™ Retractable Safety Syr… | 2009 |
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 22 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K092430.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringes is designed to aid in the prevention of needle stick injuries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162030: 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162030
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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