Atlas FDA

Trilogy Evo Universal

FDA 510(k) clearance K181170 · decided 2019-07-18

Clearance details

K-number
K181170
Device name
Trilogy Evo Universal
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 Universal, Software Version 1.05.15.00. Continuous home-us recall (Z-1649-2026)Philips Respironics, Inc.2026-04-02
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-us recall (Z-1617-2026)Philips Respironics, Inc.2026-03-26
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-i recall (Z-0292-2025)Philips Respironics, Inc.2024-11-13
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux recall (Z-2942-2024)Philips Respironics, Inc.2024-09-05
Trilogy Evo Universal Ventilator, Model No. DS2000X11B recall (Z-2943-2024)Philips Respironics, Inc.2024-09-05
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B T recall (Z-2944-2024)Philips Respironics, Inc.2024-09-05
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult p recall (Z-1504-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for recall (Z-1505-2024)Philips Respironics, Inc.2024-04-17
Trilogy Evo Universal Ventilator, Model Number DS2000X11B recall (Z-1652-2023)Philips Respironics, Inc.2023-06-02
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B recall (Z-1289-2023)Philips Respironics, Inc.2023-04-03
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo vent recall (Z-0493-2022)Philips Respironics, Inc.2022-01-22
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilo recall (Z-0494-2022)Philips Respironics, Inc.2022-01-22