Cleared Traditional

Hospira Sapphire Sets

K160492 · Hospira, Inc. · General Hospital
Dec 2016
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K160492 is an FDA 510(k) clearance for the Hospira Sapphire Sets, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 6, 2016, 288 days after receiving the submission on February 22, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K160492 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MRZ — Accessories, Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725