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."
97–120 of 174
Search insights Median review: 90d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Dec 20, 2001
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · MNS
Respironics, Inc.
Anesthesiology · 150d
Cleared Jun 28, 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714 · BZD
Respironics, Inc.
Anesthesiology · 24d
Cleared Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · BZD
Respironics, Inc.
Anesthesiology · 59d
Cleared Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · MQM
Respironics, Inc.
Chemistry · 70d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · LEL
Respironics, Inc.
Neurology · 88d
Cleared Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · BZD
Respironics, Inc.
Anesthesiology · 28d
Cleared Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · BZD
Respironics, Inc.
Anesthesiology · 190d
Cleared Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · BZD
Respironics, Inc.
Anesthesiology · 86d
Cleared May 12, 2000
ESPIRT
K001208 · CBK
Respironics, Inc.
Anesthesiology · 28d
Cleared Mar 20, 2000
BIPAP SYNCHRONY HC
K992530 · MNS
Respironics, Inc.
Anesthesiology · 236d
Cleared Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
K992969 · BZD
Respironics, Inc.
Anesthesiology · 68d
Cleared Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared Oct 27, 1999
ARIA LX CPAP SYSTEM
K993307 · BZD
Respironics, Inc.
Anesthesiology · 23d
Cleared Aug 13, 1999
MONARCH II MINI MASK
K992336 · BZD
Respironics, Inc.
Anesthesiology · 31d
Cleared May 28, 1999
REUSABLE CONTOUR II NASAL MASK
K991648 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared May 24, 1999
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · MNT
Respironics, Inc.
Anesthesiology · 90d
Cleared May 19, 1999
BIPAP HARMONY S/T, MODEL 1001445
K984407 · MNS
Respironics, Inc.
Anesthesiology · 161d
Cleared May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · LBI
Respironics, Inc.
General Hospital · 6d
Cleared Apr 19, 1999
SMARTRECORDER, MODEL 2500
K990199 · MNR
Respironics, Inc.
Anesthesiology · 88d
Cleared Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · MQM
Respironics, Inc.
Chemistry · 183d
Cleared Nov 12, 1998
ESPRIT VENTILATOR
K981072 · CBK
Respironics, Inc.
Anesthesiology · 233d
Cleared Nov 03, 1998
BIPAP VISION VENTILATORY SUPPORT
K982454 · MNT
Respironics, Inc.
Anesthesiology · 111d
Cleared Oct 05, 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · BZQ
Respironics, Inc.
Anesthesiology · 75d
Cleared May 14, 1998
STARDUST
K973920 · MNR
Respironics, Inc.
Anesthesiology · 211d