Cleared Traditional

CADD Yellow High Volume Administration Set with NRFit connector

K172592 · Smiths Medical Asd, Inc. · General Hospital

May 2018

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K172592 is an FDA 510(k) clearance for the CADD Yellow High Volume Administration Set with NRFit connector, a Administrations Sets With Neuraxial Connectors (Class II — Special Controls, product code PWH), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 17, 2018, 261 days after receiving the submission on August 29, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K172592 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2017
Decision Date	May 17, 2018
Days to Decision	261 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PWH — Administrations Sets With Neuraxial Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections.