Cleared Special

K063180 - ISECURE SYRINGE CARTRIDGE HOLDER

K063180 is an FDA 510(k) clearance for ISECURE SYRINGE CARTRIDGE HOLDER, manufactured by Hospira, Inc.. The device is a Class 1 General Hospital device with product code IQG cleared through the Special 510(k) pathway after a 53-day FDA review.

K063180 · Hospira, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
53d
Days
Class 1
Risk

K063180 is an FDA 510(k) clearance for the ISECURE SYRINGE CARTRIDGE HOLDER. Classified as Adaptor, Holder, Syringe (product code IQG), Class I - General Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063180

510(k) Number K063180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2006
Decision Date December 11, 2006
Days to Decision 53 days
Submission Type Special
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
76d faster than avg
Panel avg: 129d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

IQG Device Classification - Class 1, General Controls

Product Code IQG Adaptor, Holder, Syringe
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

K063180 · ISECURE SYRINGE CARTRIDGE HOLDER
Download PDF FDA Summary Hospira, Inc.