ClearanceBrief
510(k) K181170 ยท CBK Ventilator, Continuous, Facility Use

Trilogy Evo Universal

ApplicantRespironics, Inc., Murrysville PA, US
DecisionSubstantially Equivalent, Jul 18, 2019
ReceivedMay 2, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181170

DateFirm and productCodeLinked 510(k)
Apr 2, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKNone listed
Mar 26, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKNone listed
Nov 13, 2024Philips Respironics, Inc.
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and
Open, Classified		 CBKNone listed
Sep 5, 2024Philips Respironics, Inc.
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy
Open, Classified		 NOUNone listed
Sep 5, 2024Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Open, Classified		 CBKNone listed
Sep 5, 2024Philips Respironics, Inc.
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2,
Open, Classified		 NOUNone listed
Apr 17, 2024Philips Respironics, Inc.
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Open, Classified		 CBKNone listed
Apr 17, 2024Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Open, Classified		 CBKNone listed
Jun 2, 2023Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Open, Classified		 CBKNone listed
Apr 3, 2023Philips Respironics, Inc.
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Open, Classified		 CBKNone listed
Jan 22, 2022Philips Respironics, Inc.
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who requ
Open, Classified		 CBKNone listed
Jan 22, 2022Philips Respironics, Inc.
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individua
Open, Classified		 CBKNone listed
Jul 26, 2021Philips Respironics, Inc.
Trilogy Evo Universal, Product number DS2000X11B
Open, Classified		 CBKNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.