Respironics, Inc.
Respironics, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2026, with 1 FDA device recall on record.
Top product codes for Respironics, Inc.
FDA recalls by Respironics, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Respironics, Inc.
1–100 of 173- K261262 — Altis Full Face Mask
- K243394 — AF531 Oro-Nasal SE Face Mask
- K231313 — Therapy Mask 3100 NC/SP
- K210844 — DreamWear Silicone Pillows Mask
- K210386 — Magneto Nasal Mask
- K202142 — Sleepware G3
- K201439 — Ventilator, Non-continuous (Respirator)
- K200480 — DreamStation 2 System, DreamStation 2 Advanced System
- K183226 — Care Orchestrator Essence
- K183625 — SomnaPatch
- K181166 — Trilogy Evo
- K181170 — Trilogy Evo Universal
- K181053 — Care Orchestrator
- K161411 — Care Cycle Connect Application
- K151120 — Simple T Pediatric Nasal Mask
- K152356 — Sapphire
- K150638 — AF541 SE Full Face Mask
- K150639 — AF541 EE Full Face Mask
- K142988 — Sleepware G3
- K140980 — TI NASAL MASK
- K142554 — Revolution Full Face Mask
- K140424 — RESPIRONICS REUSABLE HEATED TUBING
- K140268 — SIMPLE T YOUTH NASAL MASK
- K132168 — BRONCHOSCOPY ELBOW
- K131982 — REMSTAR AUTO A-FLEX HT
- K131994 — SOMNOLYZER 24X7
- K130077 — REMSTAR SE
- K122847 — KANGAROO NASAL MASK
- K122111 — RESPIRONICS SIMPLYCLEAR DEVICE
- K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM
- K121955 — COUGHASSIST T70 DEVICE
- K122769 — REMSTAR SE
- K121631 — SIMPLE T NASAL MASK
- K120562 — PERFORMAX PEDIATRIC EE TOTAL FACE MASK
- K120639 — PERFORMAX PEDIATRIC SE TOTAL FACE MASK
- K120145 — SIMPLE T NASAL MASK
- K113053 — BIPAP A 30 VENTILATORY SUPPORT SYSTEM
- K113068 — REMSTAR AUTO A-FLEX HT
- K111885 — SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
- K111610 — TRILOGY SERIES VENTILATOR WITH OXIMETRY
- K110405 — TRUBLUE NASAL MASK
- K110398 — RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
- K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
- K102465 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
- K103395 — PERFORMAX TOTAL FACE MASK
- K110008 — GOLIFE NASAL MASK
- K102502 — GOLIFE NASAL MASK
- K101129 — ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
- K101130 — BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
- K093905 — TRILOGY 202 VENTILATOR
- K093416 — TRILOGY 200 VENTILATOR
- K092818 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
- K092043 — BIPAP SYNCHRONY 2
- K091028 — OMNI 5 TOTAL O2 DELIVERY SYSTEM
- K091112 — RESPIRONICS SLEEPEASY CPAP SYSTEM
- K082558 — COMFORTLITE NASAL MASK
- K082654 — ENTERAL ONLY EXTENSION SET
- K081779 — GOLOX-93
- K081206 — HOMELOX
- K072723 — RESPIRONICS GOLOX
- K072996 — REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
- K063540 — BIPAP AUTOSV
- K063533 — BIPAP SYNCHRONY
- K060919 — ACTICAL
- K061870 — VITALSENSE XHR
- K061256 — SMARTMONITOR 2PS
- K061261 — L4 OXYGEN CONCENTRATOR
- K061034 — BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
- K053352 — COMFORTLITE NASAL MASK
- K052573 — STARDUST II
- K052110 — M-SERIES PRO CPAP SYTEM
- K052489 — ACTIHEART
- K050759 — BIPAP AUTO
- K050414 — PLIX
- K043006 — MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605
- K043607 — BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
- K041568 — EOCD
- K021845 — STARDUST II, MODEL 1011176
- K041010 — REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
- K040595 — ALICE 5
- K032834 — BIPAP PRO 2 BI-LEVEL SYSTEM
- K033759 — C2 NASAL MASK
- K033822 — RESPIRONICS CUSTOM I ORAL APPLIANCE
- K033823 — RESPIRONICS CUSTOM II ORAL APPLIANCE
- K040044 — HEEL SNUGGLER, MODEL 99047
- K034040 — ESPRIT VENTILATOR, MODEL V1000
- K032403 — SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
- K031656 — BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
- K031460 — MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
- K030090 — H2 HEATED HUMIDIFIER
- K023135 — IMAGE3 SE DISPOSABLE FULL FACE MASK
- K021861 — REMSTAR PRO WITH C-FLEX CPAP SYSTEM
- K020777 — BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
- K012633 — RESPIRONICS HEATED HUMIDIFIER
- K012554 — REMSTAR AUTO CPAP SYSTEM
- K012323 — BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
- K011714 — BIPAP PRO BI-LEVEL SYSTEM
- K010263 — REMSTAR PLUS CPAP SYSTEM
- K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
- K003499 — REMVIEW SLEEP RECORDER, MODEL 320
Data sourced from openFDA. This site is unofficial and independent of the FDA.