Cleared Abbreviated

RESPIRONICS SIMPLYCLEAR DEVICE

K122111 · Respironics, Inc. · Anesthesiology
Dec 2012
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K122111 is an FDA 510(k) clearance for the RESPIRONICS SIMPLYCLEAR DEVICE, a Intra-pulmonary Percussive Vibration (ipv) Devices (Class II — Special Controls, product code SDT), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 31, 2012, 167 days after receiving the submission on July 17, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5665.

Submission Details

510(k) Number K122111 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2012
Decision Date December 31, 2012
Days to Decision 167 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code SDT — Intra-pulmonary Percussive Vibration (ipv) Devices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5665
Definition It Is Intended To Mobilize Mucus Using Vibration And/or Pressure Delivered Through A Mouthpiece Into The Airways.