Cleared Special

K091268 - HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

K091268 is an FDA 510(k) clearance for HOSPIRA LATEX-FREE CRITICAL CARE AND AD..., manufactured by Hospira, Inc.. The device is a Class 2 Cardiovascular device with product code DQE cleared through the Special 510(k) pathway after a 141-day FDA review.

K091268 · Hospira, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
141d
Days
Class 2
Risk

K091268 is an FDA 510(k) clearance for the HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS. Classified as Catheter, Oximeter, Fiber-optic (product code DQE), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on September 18, 2009 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1230 - the FDA cardiovascular device oversight 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. Standard predicate reliance. 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 - K091268

510(k) Number K091268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2009
Decision Date September 18, 2009
Days to Decision 141 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

DQE Device Classification - Class 2, Special Controls

Product Code DQE Catheter, Oximeter, Fiber-optic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1230
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQE Catheter, Oximeter, Fiber-optic

All 16
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K091268.
PreSep Oligon Oximetry Catheter
K160645 · Edwards Lifesciences, LLC · Jun 2016
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
K140129 · Icu Medical, Inc. · Jul 2014
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · Edwards Lifesciences, LLC · Feb 2011
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
K062999 · Hospira, Inc. · Nov 2006
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585 · Hospira, Inc. · Oct 2006
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS
K061450 · Hospira, Inc. · Aug 2006
K091268 · HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
Download PDF FDA Summary Hospira, Inc.