Cleared Traditional

Care Cycle Connect Application

K161411 · Respironics, Inc. · Anesthesiology
Feb 2017
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K161411 is an FDA 510(k) clearance for the Care Cycle Connect Application, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 17, 2017, 273 days after receiving the submission on May 20, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K161411 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2016
Decision Date February 17, 2017
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MOD — Accessory To Continuous Ventilator (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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