Cleared Traditional

K240915 - ZIEN IO Intraosseous Access System

K240915 is an FDA 510(k) clearance for ZIEN IO Intraosseous Access System, manufactured by Zien Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K240915 · Zien Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
90d
Days
Class 2
Risk

K240915 is an FDA 510(k) clearance for the ZIEN IO Intraosseous Access System. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Zien Medical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 2, 2024 after a review of 90 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 Zien Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K240915

510(k) Number K240915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2024
Decision Date July 02, 2024
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K240915.
Safety Winged Blood Collection Sets
K243806 · Promisemed Hangzhou Meditech Co., Ltd. · Jan 2025
ACE Cannula
K242741 · Ace Medical Industry Co., Ltd. · Jan 2025
Verifine® Pen Needles
K242632 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2024
Sterile Safety Hypodermic Needles for Single Use
K232165 · Berpu Medical Technology Co., Ltd. · Feb 2024
Sterile Hypodermic Needles for Single Use
K233037 · Zhejiang Kindly Medical Device Co., Ltd. · Dec 2023
SteriCap Safety Needle
K233343 · Ocuject, LLC · Nov 2023