Cleared Traditional

K192551 - 1ml Luer Slip or Luer Lock Syringe

K192551 is the FDA 510(k) clearance for 1ml Luer Slip or Luer Lock Syringe by Jiangsu Caina Medical Co.,Ltd. It is a Class 2 General Hospital device (product code MEG) cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K192551 · Jiangsu Caina Medical Co.,Ltd · General Hospital
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Aug 2020
Decision
328d
Days
Class 2
Risk

K192551 is an FDA 510(k) clearance for the 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle,.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on August 10, 2020 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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. 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 Jiangsu Caina Medical Co.,Ltd devices

Submission Details

510(k) Number K192551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date August 10, 2020
Days to Decision 328 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
199d slower than avg
Panel avg: 129d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
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 Peers - MEG Syringe, Antistick

All 41
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K192551.
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · Zhuhai DR Medical Instruments Co., Ltd. · Sep 2021
Insulin Syringe, Insulin Syringe with Safety Retractable
K202570 · Jiangsu Micsafe Medical Technology Co., Ltd. · Jul 2021
TK Insulin Syringe with/without Saftey Retractable Device
K191639 · Anhui Tiankang Medical Technology Co., Ltd. · Sep 2020
Retractable Safety Insulin Syringe
K193022 · Jiangsu Caina Medical Co.,Ltd · Jul 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
K192679 · Gemtier Medical (Shanghai), Inc. · Apr 2020
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
K190183 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Oct 2019