Cleared Traditional

K230635 - Pen Needle

K230635 is the FDA 510(k) clearance for Pen Needle by Jiangsu Caina Medical Co.,Ltd. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K230635 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
87d
Days
Class 2
Risk

K230635 is an FDA 510(k) clearance for the 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 June 2, 2023 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jiangsu Caina Medical Co.,Ltd devices

Submission Details

510(k) Number K230635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2023
Decision Date June 02, 2023
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K230635.
NovoFine® Plus
K231255 · Novo Nordisk, Inc. · Aug 2023
Altaviz Needle Kit II
K231261 · Altaviz, LLC · Jul 2023
EZ-IO Intraosseous Vascular Access System
K231924 · Teleflex Medical · Jul 2023
Nipro SafeTouch Needle
K222852 · Nipro Medical Corporation · May 2023
Disposable Insulin Pen Needle
K222739 · Hantech Medical Device Co., Ltd. · Apr 2023
Shina Safety Needle
K222417 · Shina Corporation · Mar 2023