Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

174 results for "Respironics, Inc."
1–24 of 174
Search insights Median review: 90d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Sep 25, 2026
Altis Full Face Mask
K261262 · BZD
Respironics, Inc.
Anesthesiology · 162d
Cleared Dec 30, 2024
AF531 Oro-Nasal SE Face Mask
K243394 · CBK
Respironics, Inc.
Anesthesiology · 60d
Cleared Jul 28, 2023
Therapy Mask 3100 NC/SP
K231313 · BZD
Respironics, Inc.
Anesthesiology · 84d
Cleared Aug 24, 2021
DreamWear Silicone Pillows Mask
K210844 · BZD
Respironics, Inc.
Anesthesiology · 155d
Cleared Jul 12, 2021
Magneto Nasal Mask
K210386 · BZD
Respironics, Inc.
Anesthesiology · 153d
Cleared Oct 29, 2020
Sleepware G3
K202142 · OLZ
Respironics, Inc.
Neurology · 90d
Cleared Sep 25, 2020
Ventilator, Non-continuous (Respirator)
K201439 · BZD
Respironics, Inc.
Anesthesiology · 116d
Cleared Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
K200480 · BZD
Respironics, Inc.
Anesthesiology · 134d
Cleared CT Oct 18, 2019
SomnaPatch
K183625 · MNR
Respironics, Inc.
Anesthesiology · 296d
Cleared Oct 18, 2019
Care Orchestrator Essence
K183226 · BZD
Respironics, Inc.
Anesthesiology · 332d
Cleared Jul 18, 2019
Trilogy Evo Universal
K181170 · CBK
Respironics, Inc.
Anesthesiology · 442d
Cleared Jul 18, 2019
Trilogy Evo
K181166 · CBK
Respironics, Inc.
Anesthesiology · 442d
Cleared Jan 04, 2019
Care Orchestrator
K181053 · BZD
Respironics, Inc.
Anesthesiology · 259d
Cleared Feb 17, 2017
Care Cycle Connect Application
K161411 · MOD
Respironics, Inc.
Anesthesiology · 273d
Cleared Apr 15, 2016
Simple T Pediatric Nasal Mask
K151120 · BZD
Respironics, Inc.
Anesthesiology · 354d
Cleared Jan 08, 2016
Sapphire
K152356 · BZD
Respironics, Inc.
Anesthesiology · 141d
Cleared Sep 18, 2015
AF541 EE Full Face Mask
K150639 · BZD
Respironics, Inc.
Anesthesiology · 191d
Cleared Sep 18, 2015
AF541 SE Full Face Mask
K150638 · CBK
Respironics, Inc.
Anesthesiology · 191d
Cleared Mar 16, 2015
Sleepware G3
K142988 · OLZ
Respironics, Inc.
Neurology · 151d
Cleared Feb 10, 2015
TI NASAL MASK
K140980 · BZD
Respironics, Inc.
Anesthesiology · 300d
Cleared Jan 09, 2015
Revolution Full Face Mask
K142554 · BZD
Respironics, Inc.
Anesthesiology · 120d
Cleared Nov 14, 2014
RESPIRONICS REUSABLE HEATED TUBING
K140424 · BZE
Respironics, Inc.
Anesthesiology · 268d
Cleared Oct 20, 2014
SIMPLE T YOUTH NASAL MASK
K140268 · BZD
Respironics, Inc.
Anesthesiology · 250d
Cleared Nov 20, 2013
BRONCHOSCOPY ELBOW
K132168 · BZD
Respironics, Inc.
Anesthesiology · 131d