Cleared Special

K060806 - HOSPIRA GEMSTAR INFUSION PUMP SYSTEM

Also marketed or referenced as:
6 THERAPY, MODEL 13086 PAIN MANAGEMENT, MODEL 13088

K060806 is the FDA 510(k) clearance for HOSPIRA GEMSTAR INFUSION PUMP SYSTEM by Hospira, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Special 510(k) pathway after a 28-day FDA review.

K060806 · Hospira, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
28d
Days
Class 2
Risk

K060806 is an FDA 510(k) clearance for the HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 21, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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.

View all Hospira, Inc. devices

Submission Details

510(k) Number K060806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2006
Decision Date April 21, 2006
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 373
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K060806.
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K062699 · B.Braun Medical, Inc. · Oct 2006
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K062700 · B.Braun Medical, Inc. · Oct 2006
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · Medrad, Inc. · May 2006
WILLCARE, MODEL GW-1020
K052594 · Icu Medical, Inc. · Feb 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005