Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe— 510(k) K253110
Substantially EquivalentSol-Millennium Medical, Inc.
FDA 510(k) clearance K253110 for Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe, Substantially Equivalent on 2026-06-18. Applicant: Sol-Millennium Medical, Inc.. Device class: 2.
Summary
Sol-Millennium Medical's clearance covers the Sol-Glide Safety Needle and the Sol-Glide Safety Needle with Syringe. The record lists one product code, FMF, piston syringes, and gives no gauges or sizes.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
Sol-Millennium filed from Chicago, Illinois. The decision came 267 calendar days after FDA received it (September 24, 2025 to June 18, 2026).
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
view all- K262581 — GraftGun Universal Graft Delivery System (GDS®)
- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
- K260208 — Ultra-Fine SAFETY Insulin 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- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- 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
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.