Cleared Traditional

Safety Blood Collection Device for Single Use (K170276) - FDA 510(k) Clearance

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

K170276 · Gemtier Medical (Shanghai), Inc. · General Hospital
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Dec 2017
Decision
315d
Days
Class 2
Risk

K170276 is an FDA 510(k) clearance for the Safety Blood Collection Device for Single Use. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Gemtier Medical (Shanghai), Inc. (Shanghai, CN). The FDA issued a Cleared decision on December 11, 2017 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gemtier Medical (Shanghai), Inc. devices

Submission Details

510(k) Number K170276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date December 11, 2017
Days to Decision 315 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
186d slower than avg
Panel avg: 129d · This submission: 315d
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 201
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K170276.
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BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
BD SafeAssist
K161553 · Becton, Dickinson and Company · Jul 2016