Cleared Traditional

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set (K182146) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182146 · Sol-Millennium Medical, Inc. · General Hospital
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Dec 2018
Decision
117d
Days
Class 2
Risk

K182146 is an FDA 510(k) clearance for the Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol.... Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on December 3, 2018 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sol-Millennium Medical, Inc. devices

Submission Details

510(k) Number K182146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2018
Decision Date December 03, 2018
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 199
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K182146.
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K180395 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Nov 2018
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K181069 · Zhejiang Kindly Medical Devices Co., Ltd. · Aug 2018