ClearanceBrief
Company ยท US

Philips Respironics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2024. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
94recalls (8 in 12 months)
76recalls that name a 510(k)

Product codes

CodeDeviceRecords
CBKVentilator, Continuous, Facility Use54
MNSVentilator, Continuous, Non-Life-Supporting18
BZDVentilator, Non-Continuous (Respirator)11
MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator7
NOUContinuous, Ventilator, Home Use5
CAWGenerator, Oxygen, Portable1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 31, 2024K233555AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
Philips Respironics
BZD
Oct 4, 2011K111378OXIMETRY INTERFACE KIT
Philips Respironics, Inc.
MNS

Latest recalls

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		 CBKK181170
Apr 2, 2026Philips Respironics, Inc.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKK181166
Apr 2, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKK181166
Apr 2, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKK181166
Mar 26, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKK181170
Mar 26, 2026Philips Respironics, Inc.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKNone listed
Mar 26, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKNone listed
Mar 26, 2026Philips Respironics, Inc.
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Open, Classified		 CBKK181166
Nov 7, 2025Philips Respironics, Inc.
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Open, Classified		 CAWNone listed
Aug 8, 2025Philips Respironics, Inc.
DreamStation Auto. Non-Continuous Ventilator.
Open, Classified		 BZDK131982
Aug 8, 2025Philips Respironics, Inc.
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Open, Classified		 BZDK131982
Aug 8, 2025Philips Respironics, Inc.
DreamStation Auto CPAP. Non-Continuous Ventilator.
Open, Classified		 BZDK131982
Jul 2, 2025Philips Respironics, Inc.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Open, Classified		 MNTK121623
Jul 2, 2025Philips Respironics, Inc.
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilati
Open, Classified		 MNSK113053
Jul 2, 2025Philips Respironics, Inc.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Open, Classified		 MNSNone listed
Nov 13, 2024Philips Respironics, Inc.
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency tran
Open, Classified		 CBKNone listed
Nov 13, 2024Philips Respironics, Inc.
Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transp
Open, Classified		 CBKNone listed
Nov 13, 2024Philips Respironics, Inc.
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transpo
Open, Classified		 CBKNone listed
Nov 13, 2024Philips Respironics, Inc.
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR
Open, Classified		 CBKK181166
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		 CBKK181170
Nov 13, 2024Philips Respironics, Inc.
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB
Open, Classified		 CBKK181166
Nov 13, 2024Philips Respironics, Inc.
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN
Open, Classified		 CBKK181166
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		 NOUK181170
Sep 5, 2024Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Open, Classified		 CBKK181170
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		 NOUK181170
May 24, 2024Philips Respironics, Inc.
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1
Open, Classified		 MNSNone listed
May 24, 2024Philips Respironics, Inc.
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R11
Open, Classified		 MNTNone listed
May 24, 2024Philips Respironics, Inc.
BiPAP V30 Auto Ventilator, Part Number 1111178
Open, Classified		 MNSNone listed
May 23, 2024Philips Respironics, Inc.
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Open, Classified		 MNSK090539
K113068 +1
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		 CBKK181170
Apr 17, 2024Philips Respironics, Inc.
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Open, Classified		 CBKK181170
Apr 17, 2024Philips Respironics, Inc.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Open, Classified		 CBKK181166
Apr 17, 2024Philips Respironics, Inc.
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Open, Classified		 CBKK181166
Apr 17, 2024Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Open, Classified		 CBKK181166
Apr 17, 2024Philips Respironics, Inc.
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Open, Classified		 CBKK181166
Apr 17, 2024Philips Respironics, Inc.
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Open, Classified		 CBKK181166
Jan 4, 2024Philips Respironics, Inc.
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B
Open, Classified		 CBKK181166
Sep 28, 2023Philips Respironics, Inc.
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Open, Classified		 MNTK102985
Jul 7, 2023Philips Respironics, Inc.
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Open, Classified		 CBKK181166
Jun 2, 2023Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Open, Classified		 CBKK181170
Jun 2, 2023Philips Respironics, Inc.
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Open, Classified		 CBKK181166
Jun 2, 2023Philips Respironics, Inc.
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B
Open, Classified		 CBKK181166
Jun 2, 2023Philips Respironics, Inc.
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2
Open, Classified		 CBKK181166
Apr 6, 2023Philips Respironics, Inc.
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment o
Open, Classified		 BZDK131982
Apr 3, 2023Philips Respironics, Inc.
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Open, Classified		 CBKK181170
Apr 3, 2023Philips Respironics, Inc.
Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B
Open, Classified		 CBKK181166
Apr 3, 2023Philips Respironics, Inc.
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR210
Open, Classified		 CBKK181166
Jan 6, 2023Philips Respironics, Inc.
Philips Garbin Ventilator, Model Number 1058180B
Open, Classified		 CBKK083526
Jan 6, 2023Philips Respironics, Inc.
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Open, Classified		 CBKK093416
Jan 6, 2023Philips Respironics, Inc.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU10
Open, Classified		 CBKK083526

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