Respironics, Inc.
Respironics, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2026, with 1 FDA device recall on record.
Clearances by Respironics, Inc. — page 2
101–173 of 173- K000705 — RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
- K002465 — SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
- K000994 — BIPAP DUET LX BI-LEVEL SYSTEM
- K001208 — ESPIRT
- K992530 — BIPAP SYNCHRONY HC
- K992969 — RESPIRONICS TOTAL FACE MASK
- K993307 — ARIA LX CPAP SYSTEM
- K993433 — VIRTUOSO LX SMART CPAP SYSTEM
- K992336 — MONARCH II MINI MASK
- K991648 — REUSABLE CONTOUR II NASAL MASK
- K990574 — STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
- K984407 — BIPAP HARMONY S/T, MODEL 1001445
- K991627 — WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
- K990199 — SMARTRECORDER, MODEL 2500
- K983071 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
- K981072 — ESPRIT VENTILATOR
- K982454 — BIPAP VISION VENTILATORY SUPPORT
- K982550 — BROWSER (EVENT SOFTWARE) MODEL # 4500E
- K973920 — STARDUST
- K973875 — RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
- K972829 — CRICKET 2000 RECORDING PULSE OXIMETER
- K963761 — QUARTET CLINICAL SYSTEM
- K964653 — OASIS HUMIDIFIER
- K964363 — BIPAP DUET SYSTEM
- K955324 — BIPAP S/T-D 30 SYSTEM
- K962203 — WHISPER SWIVEL II EXHALATION PORT
- K963250 — PRESSURE VALVE
- K963550 — RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
- K953930 — VIRTUOSO SMART CPAP SYSTEM
- K961915 — SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
- K951264 — BIPAP MODEL S/T-D
- K961626 — SOLO CPAP SYSTEM
- K954572 — MAESTRO CLINICAL REMOTE CONTROL
- K945782 — HUMIDIFIER
- K945938 — RESPIRONICS MONARCH MINI MASK
- K954207 — GEL MASK
- K953341 — ARIA CPAP SYSTEM
- K936047 — SPECTRUM(TM) MASK
- K934699 — RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
- K940581 — BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
- K934310 — BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
- K925587 — NASAL/ORAL MASK
- K924341 — HAYEK OSCILLATOR(TM)
- K925920 — TOTAL FACE MASK
- K920699 — REMSTAR WTIH RAMP AND REMOTE MODIFICATION
- K921726 — HAYEK OSCILLATOR, MODIFICATION
- K911856 — RESPIRONICS REMSTAR WITH REMOTE AND RAMP
- K904935 — RESPIRONICS' DIGITAL MANOMETER
- K905540 — RESPIRONICS BIPAP REMOTE CONTROL UNIT
- K902276 — RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
- K900113 — RESPIRONICS' REMSTAR(TM) SLEEPEASY
- K895849 — RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
- K895351 — RESPIRONICS INFANT BAGEASY
- K890795 — RESPIRONICS SEALEASY II
- K883825 — MODIFIED SANDERS BI-PAPEASY
- K882079 — RESPIRONIC'S INFANT SECUREEASY
- K882017 — RESPIRONICS SUCTIONEASY
- K871523 — RESPIRONICS SANDERS BIPAPEASY
- K863172 — RESPIRONICS PTL REVIVEEASY
- K863171 — RESPIRONICS PROTECTEASY
- K860845 — RESPIRONICS SECUREASY
- K851396 — SANDER'S MASKCPAP BY RESPIRONICS
- K843889 — RESPIRONICS SLEEPEASY NASAL CPAP SYS
- K842693 — RESPIRONICS VENTEASY
- K842605 — RESPIRONICS VENT EASY OXYGEN ENRICHME
- K833328 — RESPIRONICS RESCUE DOME
- K833748 — RESCUE VALVE
- K833327 — RESPIRONICS PR VALVE
- K822794 — RESPIRONICS ENDO TUBE CONTROL SYS
- K821384 — EXERCISE ECG ELECTRODES, REUSABLE
- K810991 — HEADSTRAP
- K770123 — EXERCISE RESPIRATORY GAS ANALYZER
- K770038 — MONITOR, HEARTWATCH HEART RATE
Data sourced from openFDA. This site is unofficial and independent of the FDA.