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510(k) K160492

Hospira Sapphire Sets by Hospira, Inc. — Product Code MRZ

K160492 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "Hospira Sapphire Sets". The FDA issued a decision of Substantially Equivalent on December 6, 2016. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Hospira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2016
Date Received
February 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Hospira, Inc.

  • K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (March 28, 2017)
  • K161036 — Hospira Extension Set, Hospira Primary Set (January 6, 2017)
  • K160870 — Hospira Administration Sets (June 1, 2016)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K143087 — Hospira Blood Set (March 4, 2015)
  • K143015 — Hospira Primary Sets (February 25, 2015)
  • K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODU (January 16, 2015)
  • K142622 — IV Administration (January 15, 2015)
  • K142974 — Extension Sets (January 9, 2015)
  • K142433 — Hospira Extension Set (December 8, 2014)

Other clearances for product code MRZ

  • K230718 — UTC 3mL Medication Cartridge (June 15, 2023)
  • K220695 — Elite Biomedical Solutions Dose Request Cord (April 29, 2022)
  • K201634 — RG 3ml Medication Cartridge (March 26, 2021)
  • K193654 — BlueStar Rx (April 7, 2020)
  • K191910 — SpaceStation MRI (March 12, 2020)
  • K190013 — WellDoc BlueStar (November 4, 2019)
  • K173531 — Lockbox for Perfusor Space PCA Infusion Pump (August 2, 2018)
  • K171346 — Sapphire Sets (August 25, 2017)
  • K162532 — WellDoc BlueStar, WellDoc BlueStar Rx (January 12, 2017)
  • K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (November 22, 2016)

FDA data resources