Cleared Traditional

K163161 - Sterile Single-use Syringe with Needle

K163161 is an FDA 510(k) clearance for Sterile Single-use Syringe with Needle, manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K163161 · Jiangxi Hongda Medical Equipment Group , Ltd. · General Hospital
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Mar 2017
Decision
130d
Days
Class 2
Risk

K163161 is an FDA 510(k) clearance for the Sterile Single-use Syringe with Needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangxi Hongda Medical Equipment Group , Ltd. (Nanchang, CN). The FDA issued a Cleared decision on March 20, 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 880.5860 - 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 Jiangxi Hongda Medical Equipment Group , Ltd. devices

FDA 510(k) Submission Details - K163161

510(k) Number K163161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date March 20, 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
Combination Product No
PCCP Authorized No
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.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 549
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K163161.
CompuFlo Epidural Computer Controlled Anesthesia System
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K162057 · Conceptomed AS · Jan 2017