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

DateFirm and productCodeLinked 510(k)
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
Feb 23, 2024Ventec Life Systems, Inc.
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermi
Open, Classified
CBKK162877
Jan 17, 2024Percussionaire Corporation
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Open, Classified
CBKK905234
Jan 17, 2024Percussionaire Corporation
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Open, Classified
CBKK905235
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
Nov 7, 2023Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Completed
CBKK905235
Oct 23, 2023ResMed Ltd.
Astral 100 and Astral 150 ventilators
Open, Classified
CBKK172875
Sep 20, 2023Hamilton Medical, Inc.
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Open, Classified
CBKNone listed
Sep 20, 2023Hamilton Medical, Inc.
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Open, Classified
CBKNone listed
Sep 20, 2023Hamilton Medical, Inc.
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Open, Classified
CBKK153046
Sep 20, 2023Hamilton Medical, Inc.
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Open, Classified
CBKK181216
Sep 20, 2023Hamilton Medical, Inc.
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Open, Classified
CBKK181216
Sep 20, 2023Hamilton Medical, Inc.
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Open, Classified
CBKK181216
Aug 18, 2023Draeger Medical, Inc.
Carina Sub-Acute Care Ventilator
Open, Classified
CBKK072885
Jul 21, 2023Hamilton Medical, Inc.
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Open, Classified
CBKK201306
Jul 21, 2023Hamilton Medical, Inc.
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Open, Classified
CBKK121225
Jul 21, 2023Hamilton Medical, Inc.
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Open, Classified
CBKK181216
Jul 21, 2023Hamilton Medical, Inc.
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Open, Classified
CBKK181216
Jul 8, 2023Draeger Medical, Inc.
Oxylog 3000 Plus emergency and transport ventilator
Open, Classified
CBKK103625
Jul 7, 2023Philips Respironics, Inc.
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Open, Classified
CBKK181166
Jun 15, 2023Vyaire Medical
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Completed
CBKK183364
Jun 15, 2023Vyaire Medical
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Completed
CBKK183364
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 25, 2023Hamilton Medical AG
HAMILTON-C6, REF: 160021
Open, Classified
CBKK201658
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
Feb 24, 2023Draeger Medical, Inc.
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Open, Classified
CBKK081743
Feb 24, 2023Draeger Medical, Inc.
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Open, Classified
CBKK081743
Feb 24, 2023Baxter Healthcare Corporation
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Open, Classified
CBKK170037
Feb 24, 2023Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Open, Classified
CBKK170037
Feb 24, 2023Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Open, Classified
CBKK170037
Feb 24, 2023Baxter Healthcare Corporation
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Open, Classified
CBKK170037
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
Nov 18, 2022Hamilton Medical AG
Hamilton-C6
Open, Classified
CBKK201658
Jul 21, 2022Getinge Usa Sales Inc
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 688199
Open, Classified
CBKK192604
Jul 20, 2022Getinge Usa Sales Inc
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 688200
Open, Classified
CBKK192604
K201874
Jun 27, 2022Hamilton Medical AG
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Open, Classified
CBKK201658
Jun 6, 2022GE Healthcare, LLC
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators.
Open, Classified
CBKK111116
K142679
Jun 6, 2022GE Healthcare, LLC
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Open, Classified
CBKK111116
K142679

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