Cleared Traditional

K163093 - Safety Blood Collection Set

K163093 is the FDA 510(k) clearance for Safety Blood Collection Set by Jiangsu Shenli Medical Production Co., Ltd.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K163093 · Jiangsu Shenli Medical Production Co., Ltd. · General Hospital
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Mar 2017
Decision
130d
Days
Class 2
Risk

K163093 is an FDA 510(k) clearance for the Safety Blood Collection Set. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Jiangsu Shenli Medical Production Co., Ltd. (Changzhou City, CN). The FDA issued a Cleared decision on March 14, 2017 after a review of 130 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 Jiangsu Shenli Medical Production Co., Ltd. devices

Submission Details

510(k) Number K163093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2016
Decision Date March 14, 2017
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
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 236
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