Cleared Traditional

K160492 - Hospira Sapphire Sets

K160492 is an FDA 510(k) clearance for Hospira Sapphire Sets, manufactured by Hospira, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K160492 · Hospira, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
288d
Days
Class 2
Risk

K160492 is an FDA 510(k) clearance for the Hospira Sapphire Sets. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 6, 2016 after a review of 288 days - an extended review cycle.

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

FDA 510(k) Submission Details - K160492

510(k) Number K160492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2016
Decision Date December 06, 2016
Days to Decision 288 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
159d slower than avg
Panel avg: 129d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, 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 - MRZ Accessories, Pump, Infusion

All 29
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K160492.
WellDoc BlueStar
K190013 · Welldoc, Inc. · Nov 2019
Lockbox for Perfusor Space PCA Infusion Pump
K173531 · B.Braun Medical, Inc. · Aug 2018
Sapphire Sets
K171346 · Icu Medical · Aug 2017
ONETOUCH REVEAL
K132618 · Lifescan, Inc. · Dec 2013
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
K120209 · American I.V. Products, Inc. · Apr 2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K120314 · Welldoc, Inc. · Feb 2012