Sol-Millennium Medical Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3077-2024 | Class II | Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No | May 9, 2024 |
| Z-3075-2024 | Class II | Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w | May 9, 2024 |
| Z-3074-2024 | Class II | Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/ | May 9, 2024 |
| Z-3079-2024 | Class II | Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL- | May 9, 2024 |
| Z-3078-2024 | Class II | Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space | May 9, 2024 |
| Z-3076-2024 | Class II | Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 1800 | May 9, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | April 30, 2025 |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o nee | November 20, 2024 |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | October 22, 2024 |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe | September 20, 2024 |
| K220713 | Sol-Guard Auto-disable Syringe | May 4, 2023 |
| K222744 | Sol-M Luer Lock Syringe | October 11, 2022 |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | August 30, 2022 |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Coll | December 3, 2018 |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | May 19, 2017 |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | August 19, 2016 |
| K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | June 17, 2016 |
| K132681 | SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE | May 22, 2014 |
| K123684 | SOL-CARE SAFETY NEEDLE | May 8, 2013 |