Data / Medical devices / United States / Sol-Millennium Medical, Inc.
Sol-Millennium Medical, Inc.: FDA-registered device maker in Chicago, IL, United States, 40 510(k) clearances
Sol-Millennium Medical, Inc. is registered with the FDA (registration 3014312726) in Chicago, IL, United States. It lists 34 device types. The FDA files 40 510(k) clearances under its listings, the newest dated August 25, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014312726
- Address
- 311 S Wacker Drive Suite 4100, Chicago, IL, United States, 60606
- Owner or operator
- Sol-Millennium (10035370)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 24, 2011
- Registered through
- 2026
- Brand names listed
- Antibacterial Gel Wound Dressing, Blood Lancets, Dressing, wound, hydrophilic., Droplet Insulin Syringe, Dropsafe Luer Lock Syringe with Safety Needle, Dropsafe Safety Needle, EZ Wing Plastic Cannula, Hypodermic Single Lumen Needle and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2026 | K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| June 18, 2026 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| April 30, 2025 | K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | JKA | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| November 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 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 | QNQ | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| October 22, 2024 | K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| September 20, 2024 | K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| December 1, 2023 | K231057 | Antibacterial Gel Wound Dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| November 10, 2023 | K231564 | Skin and Wound Cleanser | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| May 4, 2023 | K220713 | Sol-Guard Auto-disable Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| January 17, 2023 | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| October 11, 2022 | K222744 | Sol-M Luer Lock Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| August 31, 2022 | K221507 | Disposable Blood Lancet | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 30, 2022 | K213718 | SOL-GUARD Safety Pull Button Collection Set | JKA | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| February 17, 2022 | K210864 | Safety Pen Needle | FMI | Substantially Equivalent | Sandstone Medical (Suzhou), Inc. | accessdata.fda.gov |
| November 3, 2021 | K202732 | SOL-CARE IV Bag Safety Connector | LHI | Substantially Equivalent | Sol-Millennium Medical Group | accessdata.fda.gov |
| October 19, 2021 | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| September 8, 2021 | K210712 | Verifine Mechanical Safety Insulin Syringe | FMF | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| February 2, 2021 | K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | FMI | Substantially Equivalent | Sandstone Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 5, 2020 | K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 14, 2020 | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| December 3, 2018 | 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 | FMI | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| August 17, 2018 | K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 4, 2018 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | JKA | Substantially Equivalent | Zhejiang Kindly Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 19, 2017 | K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | JKA | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| May 11, 2017 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| August 19, 2016 | K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | MEG | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| June 17, 2016 | K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| October 21, 2015 | K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| June 20, 2014 | K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 22, 2014 | K132681 | SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE | MEG | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| May 8, 2013 | K123684 | SOL-CARE SAFETY NEEDLE | FMI | Substantially Equivalent | Sol-Millennium Medical | accessdata.fda.gov |
| February 24, 2012 | K112777 | SOL-M EXCHANGEABLE NEEDLES | FMI | Substantially Equivalent | Sol-Milennium Medical, Inc. | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
| September 16, 2011 | K111559 | SURGICAL MASKS | FXX | Substantially Equivalent | Shanghai Neo-Medical Import & Export Co., Ltd. | accessdata.fda.gov |
| August 20, 2010 | K101359 | INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) | FMF | Substantially Equivalent | Inviro Medical Devices, Inc. | accessdata.fda.gov |
| September 4, 2009 | K092430 | 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES | MEG | Substantially Equivalent | Inviro Medical Devices, Inc. | accessdata.fda.gov |
| September 4, 2009 | K092413 | INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES | MEG | Substantially Equivalent | Inviro Medical Devices, Inc. | accessdata.fda.gov |
| May 15, 2009 | K083851 | INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 | LHI | Substantially Equivalent | Inviro Medical Devices, Inc. | accessdata.fda.gov |
| February 12, 2008 | K071307 | INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 | FMI | Substantially Equivalent | Inviro Medical Devices, Inc. | accessdata.fda.gov |
| June 10, 2003 | K023755 | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | FXX | Substantially Equivalent | Winner Industries (Shenzhen) Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 9, 2024 | 94968 | Class II | Ongoing | 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 1/2'', Model No. 1831815B, | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. | accessdata.fda.gov |
Compare with other makers
- All makers of Bedding, Disposable, Medical
- All makers of Tubing, Noninvasive
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Mask, Surgical
- All makers of Set, Administration, Intravascular
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.