Sapphire Sets
FDA 510(k) K171346 · Icu Medical
510(k) numberK171346
Submission
- Device name
- Sapphire Sets
- Applicant
- Icu Medical
Lake Forest, IL, US - Received
- May 8, 2017
- Decision date
- August 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K193654 | BlueStar RxMRZ · Traditional | Welldoc, Inc. | 04/07/2020SE |
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| K190013 | WellDoc BlueStarMRZ · Traditional | Welldoc, Inc. | 11/04/2019SE |
| K173531 | Lockbox for Perfusor Space PCA Infusion PumpMRZ · Traditional | B.Braun Medical, Inc. | 08/02/2018SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | Welldoc, Inc. | 01/12/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | Hospira, Inc. | 12/06/2016SE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ · Traditional | Welldoc, Inc. | 11/22/2016SE |
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| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2025SE |
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| K242114 | Plum Solo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
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Questions and answers
When was Sapphire Sets cleared by the FDA?
Sapphire Sets (K171346) received a 510(k) decision of Substantially Equivalent on August 25, 2017, 109 days after the submission was received.
What is the product code of K171346?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.