SOL-M Luer Lock Syringe with Exchangeable Needle Tray— 510(k) K252184
Substantially EquivalentSol-Millennium Medical, Inc.
FDA 510(k) clearance K252184 for SOL-M Luer Lock Syringe with Exchangeable Needle Tray, Substantially Equivalent on 2026-08-25. Applicant: Sol-Millennium Medical, Inc.. Device class: 2.
Summary
Sol-Millennium Medical filed the SOL-M Luer Lock Syringe with Exchangeable Needle Tray under product code FMF, piston syringes. The record has no model numbers or other description.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel, and it was a Traditional 510(k).
Sol-Millennium filed from Chicago, Illinois. The decision came 410 calendar days after FDA received it (July 11, 2025 to August 25, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Sol-Millennium Medical, Inc.
- Product code
- Product code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code FMF
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- K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
- K260208 — Ultra-Fine SAFETY Insulin Syringe
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
More clearances from Sol-Millennium Medical, Inc.
view all- K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
- 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
- K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
- K241821 — Luer Lock Syringe with Safety Needle +2 more
- K220713 — Sol-Guard Auto-disable Syringe
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.