510(k) Report

FDA applicant

Sol-Millennium Medical, Inc.

Chicago, IL16 decisions2013–20262 recalls

FDA records 16 decisions for Sol-Millennium Medical, Inc. (Chicago, IL) from 2013 to 2026: 16 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 176 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Sol-Millennium Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Sol-Millennium Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12014: 12016: 22017: 12018: 12022: 22023: 12024: 32025: 12026 (partial year): 3
2013high 3 (2024) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2020

2020: 2
2013high 2 (2020) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Sol-Millennium Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sol-Millennium Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FMFSyringe, Piston7decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection4decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • MEGSyringe, Antistick2decisions
  • QNQLow Dead Space Piston Syringe1decision

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 176 days; 8 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123684Sol-Care Safety NeedleSol-Millennium Medical · 20132cite it
  • K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle…Sol-Millennium Medical, Inc. · 20242cite it
  • K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with…Sol-Millennium Medical, Inc. · 20242cite it
  • K132681Sol-Guard Insulin and Tuberculin Safety SyringeSol-Millennium Medical, Inc. · 20142cite it
  • K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 20222cite it
  • K153537Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc. · 20162cite it

What has FDA decided for it lately?

  • K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026
  • K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2025
  • K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle…Sol-Millennium Medical, Inc. · 2024
  • K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc. · 2024
  • K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with…Sol-Millennium Medical, Inc. · 2024
  • K220713Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc. · 2023

All 15 as Sol-Millennium Medical, Inc. →The one decision as Sol-Millennium Medical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K123684Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for…Jan 15, 2020Class II
  • K123684Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for…Jan 15, 2020Class II