Medical Device Manufacturer · US , Monroeville , PA

Respironics, Inc.

172 submissions · 168 cleared · Since 1977
172
Total
168
Cleared
0
Denied

Respironics, Inc. — FDA 510(k) Submissions

Respironics, Inc. has submitted 172 FDA 510(k) premarket notifications since 1977, of which 168 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Non-continuous (respirator), Ventilator, Continuous, Facility Use, Ventilator, Continuous, Non-life-supporting, Ventilator, Continuous, Minimal Ventilatory Support, Facility Use, Ventilatory Effort Recorder . Use the specialty filter in the sidebar to narrow results.

172 devices
1–25 of 172
AF531 Oro-Nasal SE Face Mask
K243394 · CBK Ventilator, Continuous,... · Anesthesiology
Dec 2024 60d
Therapy Mask 3100 NC/SP
K231313 · BZD Ventilator,... · Anesthesiology
Jul 2023 84d
DreamWear Silicone Pillows Mask
K210844 · BZD Ventilator,... · Anesthesiology
Aug 2021 155d
Magneto Nasal Mask
K210386 · BZD Ventilator,... · Anesthesiology
Jul 2021 153d
Sleepware G3
K202142 · OLZ Automatic Event Detection... · Neurology
Oct 2020 90d
Ventilator, Non-continuous (Respirator)
K201439 · BZD Ventilator,... · Anesthesiology
Sep 2020 116d
DreamStation 2 System, DreamStation 2 Advanced System
K200480 · BZD Ventilator,... · Anesthesiology
Jul 2020 134d
Care Orchestrator Essence
K183226 · BZD Ventilator,... · Anesthesiology
Oct 2019 332d
SomnaPatch
K183625 · MNR Ventilatory Effort Recorder · Anesthesiology
Oct 2019 296d
Trilogy Evo
K181166 · CBK Ventilator, Continuous,... · Anesthesiology
Jul 2019 442d
Trilogy Evo Universal
K181170 · CBK Ventilator, Continuous,... · Anesthesiology
Jul 2019 442d
Care Orchestrator
K181053 · BZD Ventilator,... · Anesthesiology
Jan 2019 259d
Care Cycle Connect Application
K161411 · MOD Accessory To Continuous... · Anesthesiology
Feb 2017 273d
Simple T Pediatric Nasal Mask
K151120 · BZD Ventilator,... · Anesthesiology
Apr 2016 354d
Sapphire
K152356 · BZD Ventilator,... · Anesthesiology
Jan 2016 141d
AF541 SE Full Face Mask
K150638 · CBK Ventilator, Continuous,... · Anesthesiology
Sep 2015 191d
AF541 EE Full Face Mask
K150639 · BZD Ventilator,... · Anesthesiology
Sep 2015 191d
Sleepware G3
K142988 · OLZ Automatic Event Detection... · Neurology
Mar 2015 151d
TI NASAL MASK
K140980 · BZD Ventilator,... · Anesthesiology
Feb 2015 300d
Revolution Full Face Mask
K142554 · BZD Ventilator,... · Anesthesiology
Jan 2015 120d
RESPIRONICS REUSABLE HEATED TUBING
K140424 · BZE Heater, Breathing System... · Anesthesiology
Nov 2014 268d
SIMPLE T YOUTH NASAL MASK
K140268 · BZD Ventilator,... · Anesthesiology
Oct 2014 250d
BRONCHOSCOPY ELBOW
K132168 · BZD Ventilator,... · Anesthesiology
Nov 2013 131d
REMSTAR AUTO A-FLEX HT
K131982 · BZD Ventilator,... · Anesthesiology
Oct 2013 112d
SOMNOLYZER 24X7
K131994 · MNR Ventilatory Effort Recorder · Anesthesiology
Oct 2013 111d

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