Cleared Traditional

K192677 - Safety Insulin Pen Needle

K192677 is an FDA 510(k) clearance for Safety Insulin Pen 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 145-day FDA review.

K192677 · Jiangsu Caina Medical Co.,Ltd · General Hospital
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Feb 2020
Decision
145d
Days
Class 2
Risk

K192677 is an FDA 510(k) clearance for the Safety Insulin Pen 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 February 18, 2020 after a review of 145 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 Caina Medical Co.,Ltd devices

FDA 510(k) Submission Details - K192677

510(k) Number K192677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date February 18, 2020
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 Peers - FMI Needle, Hypodermic, Single Lumen

All 454
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K192677.
TK Safety Needle
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K191643 · Anhui Tiankang Medical Technology Co., Ltd. · Dec 2019
SAM IO Intraosseous Access System
K191488 · Sam? Medical Products, Inc. · Nov 2019