ClearanceBrief
Panels › Anesthesiology › Product code CBK · Class 2

Ventilator, Continuous, Facility Use

Regulation 868.5895

4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
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Top companies in CBK

Company510(k)sRecalls
Hamilton Medical AG3531
Philips Respironics054
Draeger Medical AG & Co. KG1426
Puritan Bennett Corp.341
Newport Medical Instruments, Inc.1712
Respironics, Inc.1414
Covidien423
Bird Products Corp.210
Respironics California, Inc.813
Bio-Med Devices, Inc.98
DateFirm and productCodeLinked 510(k)
Oct 20, 2026Ventec Life Systems, Inc.
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Open, Classified		 CBKNone listed
Oct 20, 2026Ventec Life Systems, Inc.
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Open, Classified		 CBKK162877
Aug 14, 2026Maquet Critical Care AB
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Open, Classified		 CBKK201874
Jul 28, 2026ResMed Ltd.
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventil
Open, Classified		 CBKK152068
K172875
Jun 23, 2026Ventec Life Systems, Inc.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Open, Classified		 CBKK162877
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
Aug 19, 2025Hamilton Medical AG
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and option
Open, Classified		 CBKK201658
Jun 27, 2025Maquet Critical Care AB
Servo-u MR Ventilator System. Model Number: 6888800.
Open, Classified		 CBKK201874
Jun 27, 2025Maquet Critical Care AB
Servo-n Ventilator System. Model Number: 6694800.
Open, Classified		 CBKK201874
Jun 27, 2025Maquet Critical Care AB
Servo-u Ventilator System. Model Number: 6688600.
Open, Classified		 CBKK201874
Jun 9, 2025Covidien
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70
Open, Classified		 CBKK111146
May 9, 2025Baxter Healthcare Corporation
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Open, Classified		 CBKK170037
May 9, 2025Baxter Healthcare Corporation
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
Open, Classified		 CBKK170037
Feb 26, 2025Ventec Life Systems, Inc.
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Open, Classified		 CBKK162877
Jan 23, 2025Percussionaire Corporation
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PA
Open, Classified		 CBKK905235
Jan 16, 2025Baxter Healthcare Corporation
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Open, Classified		 CBKK170037
Jan 16, 2025Baxter Healthcare Corporation
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Open, Classified		 CBKK170037
Jan 16, 2025Baxter Healthcare Corporation
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Open, Classified		 CBKK170037
Jan 16, 2025Baxter Healthcare Corporation
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Open, Classified		 CBKK170037
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
Oct 22, 2024Baxter Healthcare Corporation
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Open, Classified		 CBKK170037
Sep 5, 2024Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Open, Classified		 CBKK181170
Aug 2, 2024Covidien
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, P
Open, Classified		 CBKK070899
Jun 26, 2024Baxter Healthcare Corporation
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system in
Open, Classified		 CBKK170037
Jun 20, 2024ZOLL Medical Corporation
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-
Open, Classified		 CBKK111473
K162832
Jun 18, 2024Hamilton Medical AG
Ventilator HAMILTON-C6, PN: 160021
Open, Classified		 CBKK201658
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

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