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."
25–48 of 174
Search insights Median review: 90d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Oct 18, 2013
REMSTAR AUTO A-FLEX HT
K131982 · BZD
Respironics, Inc.
Anesthesiology · 112d
Cleared Oct 17, 2013
SOMNOLYZER 24X7
K131994 · MNR
Respironics, Inc.
Anesthesiology · 111d
Cleared May 21, 2013
REMSTAR SE
K130077 · BZD
Respironics, Inc.
Anesthesiology · 127d
Cleared Mar 06, 2013
KANGAROO NASAL MASK
K122847 · BZD
Respironics, Inc.
Anesthesiology · 169d
Cleared Dec 31, 2012
RESPIRONICS SIMPLYCLEAR DEVICE
K122111 · SDT
Respironics, Inc.
Anesthesiology · 167d
Cleared Dec 14, 2012
COUGHASSIST T70 DEVICE
K121955 · NHJ
Respironics, Inc.
Anesthesiology · 164d
Cleared Dec 14, 2012
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · MNT
Respironics, Inc.
Anesthesiology · 196d
Cleared Oct 09, 2012
REMSTAR SE
K122769 · BZD
Respironics, Inc.
Anesthesiology · 29d
Cleared Oct 05, 2012
SIMPLE T NASAL MASK
K121631 · BZD
Respironics, Inc.
Anesthesiology · 123d
Cleared Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562 · BZD
Respironics, Inc.
Anesthesiology · 144d
Cleared Jul 10, 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · CBK
Respironics, Inc.
Anesthesiology · 130d
Cleared Mar 30, 2012
SIMPLE T NASAL MASK
K120145 · BZD
Respironics, Inc.
Anesthesiology · 72d
Cleared Feb 01, 2012
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
K113053 · MNS
Respironics, Inc.
Anesthesiology · 111d
Cleared Dec 16, 2011
REMSTAR AUTO A-FLEX HT
K113068 · BZD
Respironics, Inc.
Anesthesiology · 60d
Cleared Nov 04, 2011
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · CAW
Respironics, Inc.
Anesthesiology · 126d
Cleared Oct 14, 2011
TRILOGY SERIES VENTILATOR WITH OXIMETRY
K111610 · CBK
Respironics, Inc.
Anesthesiology · 127d
Cleared Oct 04, 2011
OXIMETRY INTERFACE KIT
K111378 · MNS
Philips Respironics, Inc.
Anesthesiology · 140d
Cleared Jun 06, 2011
TRUBLUE NASAL MASK
K110405 · BZD
Respironics, Inc.
Anesthesiology · 112d
Cleared Jun 01, 2011
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · BZE
Respironics, Inc.
Anesthesiology · 110d
Cleared Apr 05, 2011
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · MNT
Respironics, Inc.
Anesthesiology · 180d
Cleared Mar 24, 2011
PERFORMAX TOTAL FACE MASK
K103395 · BZD
Respironics, Inc.
Anesthesiology · 125d
Cleared Mar 24, 2011
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K102465 · MNS
Respironics, Inc.
Anesthesiology · 209d
Cleared Feb 17, 2011
GOLIFE NASAL MASK
K110008 · BZD
Respironics, Inc.
Anesthesiology · 45d
Cleared Dec 22, 2010
GOLIFE NASAL MASK
K102502 · BZD
Respironics, Inc.
Anesthesiology · 112d