Company · US
Sol-Millennium Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (3 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K260857 | Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set Sol-Millennium Medical, Inc. | JKA |
| Aug 25, 2026 | K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray Sol-Millennium Medical, Inc. | FMF |
| Jun 18, 2026 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe Sol-Millennium Medical, Inc. | FMF |
| Apr 30, 2025 | K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set Sol-Millennium Medical, Inc. | JKA |
| Nov 20, 2024 | K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Sol-Millennium Medical, Inc. | QNQ |
| Oct 22, 2024 | K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle Sol-Millennium Medical, Inc. | FMF |
| Sep 20, 2024 | K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Need Sol-Millennium Medical, Inc. | FMF |
| May 4, 2023 | K220713 | Sol-Guard Auto-disable Syringe Sol-Millennium Medical, Inc. | FMF |
| Oct 11, 2022 | K222744 | Sol-M Luer Lock Syringe Sol-Millennium Medical, Inc. | FMF |
| Aug 30, 2022 | K213718 | SOL-GUARD Safety Pull Button Collection Set Sol-Millennium Medical, Inc. | JKA |
| Dec 3, 2018 | K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with H Sol-Millennium Medical, Inc. | FMI |
| May 19, 2017 | K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder Sol-Millennium Medical, Inc. | JKA |
| Aug 19, 2016 | K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle Sol-Millennium Medical, Inc. | MEG |
| Jun 17, 2016 | K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe Sol-Millennium Medical, Inc. | FMF |
| May 22, 2014 | K132681 | SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE Sol-Millennium Medical, Inc. | MEG |
| May 8, 2013 | K123684 | SOL-CARE SAFETY NEEDLE Sol-Millennium Medical | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringe Tip Caps labeled as:
1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A;
2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A;
3) SOL-M Red Cap, Model No. 110101150020, UPC N/A
Open, Classified |
KYW | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Low Dead Space labeled as:
a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;
b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Eccentric Tips labeled as:
1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551;
2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, U Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Luer Slip Tips labeled as:
1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138;
2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523 Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with exchangeable needles labeled as:
SOL-CARE:
1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858;
2) SOL-CARE 10ml Luer L Open, Classified |
FMF | None listed |
| Sep 6, 2024 | Sol-Millennium Medical Inc. Syringes with Fixed Needles labeled as:
a) SOL-M:
1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884;
2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/ Open, Classified |
FMF | None listed |