Atlas FDA

Trilogy Evo

FDA 510(k) clearance K181166 · decided 2019-07-18

Clearance details

K-number
K181166
Device name
Trilogy Evo
Applicant
Respironics, Inc.
Decision
Substantially Equivalent
Date received
2018-05-02
Decision date
2019-07-18
Days to decision
442 days
Clearance type
Traditional
Product code
CBK
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Murrysville, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilat recall (Z-1646-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use venti recall (Z-1647-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventil recall (Z-1648-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilat recall (Z-1614-2026)Philips Respironics, Inc.2026-03-26
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, recall (Z-0290-2025)Philips Respironics, Inc.2024-11-13
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, recall (Z-0291-2025)Philips Respironics, Inc.2024-11-13
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, recall (Z-0293-2025)Philips Respironics, Inc.2024-11-13
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult pat recall (Z-1499-2024)Philips Respironics, Inc.2024-04-17
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult pa recall (Z-1500-2024)Philips Respironics, Inc.2024-04-17
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult recall (Z-1501-2024)Philips Respironics, Inc.2024-04-17
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult recall (Z-1502-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adul recall (Z-1503-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13 recall (Z-0638-2024)Philips Respironics, Inc.2024-01-04
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions recall (Z-2106-2023)Philips Respironics, Inc.2023-07-07
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, recall (Z-1649-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X recall (Z-1650-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200 recall (Z-1651-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN recall (Z-1287-2023)Philips Respironics, Inc.2023-04-03
Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X1 recall (Z-1288-2023)Philips Respironics, Inc.2023-04-03
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilo recall (Z-0494-2022)Philips Respironics, Inc.2022-01-22
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for recall (Z-0942-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pedi recall (Z-0943-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for ped recall (Z-0944-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatri recall (Z-0945-2020)Philips Respironics, Inc.2020-02-15
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediat recall (Z-0946-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended f recall (Z-0947-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for ped recall (Z-0948-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pedi recall (Z-0949-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is inten recall (Z-0950-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for recall (Z-0951-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for recall (Z-0952-2020)Philips Respironics, Inc.2020-02-15
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for ped recall (Z-0953-2020)Philips Respironics, Inc.2020-02-15
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatr recall (Z-0954-2020)Philips Respironics, Inc.2020-02-15