Cleared Traditional

Care Orchestrator

K181053 · Respironics, Inc. · Anesthesiology
Jan 2019
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K181053 is an FDA 510(k) clearance for the Care Orchestrator, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 4, 2019, 259 days after receiving the submission on April 20, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K181053 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2018
Decision Date January 04, 2019
Days to Decision 259 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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