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)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2022 | Medtronic formerly Covidien Puritan Bennett 980 Series Ventilator Open, Classified |
CBK | K193056 |
| Mar 21, 2022 | Breas Medical, Inc. Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models
Article no 007384 Terminated |
CBK | None listed |
| Feb 16, 2022 | Vyaire Medical bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130.
The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adu Terminated |
CBK | K183364 |
| Feb 14, 2022 | Draeger Medical, Inc. Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 Terminated |
CBK | K093632 |
| Feb 14, 2022 | Draeger Medical, Inc. Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients
Catalog Number: 8416400 Terminated |
CBK | K093633 |
| Jan 22, 2022 | Philips 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 |
CBK | K181166 K181170 |
| Jan 22, 2022 | Philips 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 |
CBK | K181170 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1PLDIPC Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1ENNISB Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator,980X1ENAIQC Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980U3ESDIUU Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980U1ENASAA Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980S3ENDICU Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980S1ENDICU Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980A3ENNISB Terminated |
CBK | K193056 |
| Dec 9, 2021 | Covidien Llc Puritan Bennett 980 Series Ventilator, 980A1ENNISB Terminated |
CBK | K193056 |
| Sep 10, 2021 | Draeger Medical, Inc. Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and
pediatric patients from 5 kg (11 lbs) u Open, Classified |
CBK | K093632 |
| Sep 10, 2021 | Draeger Medical, Inc. Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients.
Catalog Number: 8416400 Open, Classified |
CBK | K093633 |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy Evo Universal, Product number DS2000X11B Open, Classified |
CBK | K181170 |
| Jul 20, 2021 | NIHON KOHDEN ORANGEMED, INC Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric Terminated |
CBK | K181695 K192307 |
| Jul 15, 2021 | Philips Respironics, Inc. Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. Open, Classified |
CBK | K083526 K093416 +1 |
| Jun 21, 2021 | Ventec Life Systems, Inc. Ventec Life Systems VOCSN Multi-Function Ventilator
Model/Version/Catalog Number:
V+O+C+S+N+Pro/English/PRT-00490-001;
V+O+C+S+N+Pro/Japan/PRT-00490-100;
V+C+Pro/English/PRT-00900-001;
V+C+Pro/Japan/ Open, Classified |
CBK | K162877 |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Apr 16, 2021 | Draeger Medical, Inc. Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Terminated |
CBK | None listed |
| Nov 12, 2020 | Hill-Rom Manufacturing, Inc. Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air tr Terminated |
CBK | K170037 |
| Oct 16, 2020 | Covidien Llc Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation
SKU:
980 Open, Classified |
CBK | K162738 |
| Sep 17, 2020 | Getinge Group Logistics America, LLC Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in differen Open, Classified |
CBK | K123149 |
| Aug 24, 2020 | GE Healthcare, LLC CARESCAPE R860 Ventilator
The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway press Terminated |
CBK | K142679 |
| Feb 15, 2020 | Philips Respironics, Inc. LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm Sp Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alar Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and a Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, recor Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, France - Model Number: FR2110X14B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alar Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, an Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Garbin EVO Ventilator, Linde - Model Number: LD2110X23B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm S Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, EU - Model Number: EU2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alar Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm Terminated |
CBK | K181166 |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, International, Model Number IN2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and Terminated |
CBK | K181166 |
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