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FDA 510(k)

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set

K-Number: K182146 · 2018-12-03

ApplicantSol-Millennium Medical, Inc.
Decision Date2018-12-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set is a medical device manufactured by Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2018-12-03 under approval number K182146. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set?

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set is a medical device that received FDA 510(k) clearance on 2018-12-03. It is manufactured by Sol-Millennium Medical, Inc.. The 510(k) number is K182146.

When was Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set approved by the FDA?

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set received FDA 510(k) clearance on 2018-12-03, under approval number K182146.

What company makes Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set?

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set is manufactured by Sol-Millennium Medical, Inc..

What is the FDA product code for Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set?

The FDA product code for Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set is FMI.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025) PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

Other Devices by Sol-Millennium Medical, Inc.

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed Needle K153537Sol-M Insulin Syringe, Sol-M TB Syringe K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder K222744Sol-M Luer Lock Syringe K213718SOL-GUARD Safety Pull Button Collection Set K220713Sol-Guard Auto-disable Syringe

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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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