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FDA 510(k)

SOL-M Luer Lock Syringe with Exchangeable Needle Tray

K-Number: K252184 · 2026-08-25

ApplicantSol-Millennium Medical, Inc.
Decision Date2026-08-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOL-M Luer Lock Syringe with Exchangeable Needle Tray is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K252184. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOL-M Luer Lock Syringe with Exchangeable Needle Tray?

SOL-M Luer Lock Syringe with Exchangeable Needle Tray is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K252184.

When did SOL-M Luer Lock Syringe with Exchangeable Needle Tray receive FDA 510(k) clearance?

SOL-M Luer Lock Syringe with Exchangeable Needle Tray received FDA 510(k) clearance on 2026-08-25, under 510(k) number K252184.

Who is the listed applicant for SOL-M Luer Lock Syringe with Exchangeable Needle Tray?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOL-M Luer Lock Syringe with Exchangeable Needle Tray?

The FDA product code for SOL-M Luer Lock Syringe with Exchangeable Needle Tray is FMF.

Other records listing Sol-Millennium Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeK250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetK242291SOL-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 NeedleK242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleK241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill NeedleK220713Sol-Guard Auto-disable Syringe

View all 13 devices →

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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