Cleared Traditional

K172938 - Disposable Sterile Needle

K172938 is an FDA 510(k) clearance for Disposable Sterile Needle, manufactured by Jiangsu Caina Medical Co.,Ltd. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K172938 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
261d
Days
Class 2
Risk

K172938 is an FDA 510(k) clearance for the Disposable Sterile Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on June 14, 2018 after a review of 261 days - an extended review cycle.

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 Caina Medical Co.,Ltd devices

FDA 510(k) Submission Details - K172938

510(k) Number K172938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date June 14, 2018
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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 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 - FMI Needle, Hypodermic, Single Lumen

All 304
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K172938.
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
K173881 · Owen Mumford, Ltd. · Jul 2018
Medifine Pen Needle 3 Bevel
K180720 · Medibio USA, LLC · Jun 2018
Kopac Sterile Needle
K172483 · Poonglim Pharmatech, Inc. · Jun 2018
Omnican fine
K173803 · B.Braun Medical, Inc. · Jun 2018
VACUETTE SAFELINK Holder with male luer lock
K180545 · Greiner Bio-One Na, Inc. · May 2018
Sterile Hypodermic Needle for Single Use
K180259 · Jiangsu Shenli Medical Production Co., Ltd. · May 2018