# Sol-Millennium Medical, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 16 (2013–2026): 16 510(k) clearances
- Names in FDA's records: Sol-Millennium Medical, Inc. (15); Sol-Millennium Medical (1)
- Product codes: FMF (7), JKA (4), FMI (2), MEG (2), QNQ (1)
- 510(k) review time since 2016: median 117 days, against 176 for FDA's reviews in the same codes and years (8 of 13 faster)
- Predicates its devices cite: 17 (5 its own); citations of its devices by later devices: 14 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tyco Healthcare: 2 (https://510kreport.com/company/tyco-healthcare)
- Inviro Medical Devices, Inc.: 2 (https://510kreport.com/company/inviro-medical-devices)
- Zhejiang Kindly Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-kindly-medical-devices)
- Bd Medical Systems: 1 (https://510kreport.com/company/bd-medical-systems)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Jiangsu Kangbao Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-kangbao-medical-equipment)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Firms that cite its devices most
- CMT Health PTE., Ltd.: 2 (https://510kreport.com/company/cmt-health)
- Jiangsu Caina Medical Co.,Ltd: 2 (https://510kreport.com/company/jiangsu-caina-medical)
- Promisemed Hangzhou Meditech Co., Ltd.: 2 (https://510kreport.com/company/promisemed-hangzhou-meditech)
- Exelint International, Co.: 1 (https://510kreport.com/company/exelint-international)
- The Monarch Company: 1 (https://510kreport.com/company/monarch)
- Chirana T. Injecta: 1 (https://510kreport.com/company/chirana-t-injecta)

## Its most-cited devices
- K123684: Sol-Care Safety Needle (2013), cited by 2
- 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 Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (2024), cited by 2
- K241821: Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (2024), cited by 2
- K132681: Sol-Guard Insulin and Tuberculin Safety Syringe (2014), cited by 2
- K213718: SOL-GUARD Safety Pull Button Collection Set (2022), cited by 2
- K153537: Sol-M  Insulin Syringe, Sol-M TB Syringe (2016), cited by 2

## Recent decisions
- K260857: Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set (Oct 21, 2026)
- K252184: SOL-M Luer Lock Syringe with Exchangeable Needle Tray (Aug 25, 2026)
- K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (Jun 18, 2026)
- K250907: Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (Apr 30, 2025)
- 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 Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (Nov 20, 2024)
- K242099: Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (Oct 22, 2024)
- K241821: Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (Sep 20, 2024)
- K220713: Sol-Guard Auto-disable Syringe (May 4, 2023)

Source page: https://510kreport.com/company/sol-millennium-medical