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 17, 2024 | Philips Respironics, Inc. Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Open, Classified |
CBK | K181170 |
| Apr 17, 2024 | Philips Respironics, Inc. Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Open, Classified |
CBK | K181166 |
| Apr 17, 2024 | Philips Respironics, Inc. Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Open, Classified |
CBK | K181166 |
| Apr 17, 2024 | Philips Respironics, Inc. LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Open, Classified |
CBK | K181166 |
| Apr 17, 2024 | Philips Respironics, Inc. Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Open, Classified |
CBK | K181166 |
| Apr 17, 2024 | Philips Respironics, Inc. Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Open, Classified |
CBK | K181166 |
| Feb 23, 2024 | Ventec 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 |
CBK | K162877 |
| Jan 17, 2024 | Percussionaire Corporation High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 Open, Classified |
CBK | K905234 |
| Jan 17, 2024 | Percussionaire Corporation Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) Open, Classified |
CBK | K905235 |
| Jan 4, 2024 | Philips 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 |
CBK | K181166 |
| Nov 7, 2023 | Percussionaire Corporation Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. Completed |
CBK | K905235 |
| Oct 23, 2023 | ResMed Ltd. Astral 100 and Astral 150 ventilators Open, Classified |
CBK | K172875 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator Open, Classified |
CBK | None listed |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator Open, Classified |
CBK | None listed |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-MR1, REF: 161010, Intensive Care Ventilator Open, Classified |
CBK | K153046 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Open, Classified |
CBK | K181216 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Open, Classified |
CBK | K181216 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Open, Classified |
CBK | K181216 |
| Aug 18, 2023 | Draeger Medical, Inc. Carina Sub-Acute Care Ventilator Open, Classified |
CBK | K072885 |
| Jul 21, 2023 | Hamilton 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 |
CBK | K201306 |
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C2 Ventilator
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | K121225 |
| Jul 21, 2023 | Hamilton 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 |
CBK | K181216 |
| Jul 21, 2023 | Hamilton 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 |
CBK | K181216 |
| Jul 8, 2023 | Draeger Medical, Inc. Oxylog 3000 Plus emergency and transport ventilator Open, Classified |
CBK | K103625 |
| Jul 7, 2023 | Philips Respironics, Inc. Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use Open, Classified |
CBK | K181166 |
| Jun 15, 2023 | Vyaire Medical bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator Completed |
CBK | K183364 |
| Jun 15, 2023 | Vyaire Medical bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator Completed |
CBK | K183364 |
| Jun 2, 2023 | Philips Respironics, Inc. Trilogy Evo Universal Ventilator, Model Number DS2000X11B Open, Classified |
CBK | K181170 |
| Jun 2, 2023 | Philips Respironics, Inc. Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B Open, Classified |
CBK | K181166 |
| Jun 2, 2023 | Philips 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 |
CBK | K181166 |
| Jun 2, 2023 | Philips 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 |
CBK | K181166 |
| Apr 25, 2023 | Hamilton Medical AG HAMILTON-C6, REF: 160021 Open, Classified |
CBK | K201658 |
| Apr 3, 2023 | Philips Respironics, Inc. Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B Open, Classified |
CBK | K181170 |
| Apr 3, 2023 | Philips Respironics, Inc. Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B Open, Classified |
CBK | K181166 |
| Apr 3, 2023 | Philips 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 |
CBK | K181166 |
| Feb 24, 2023 | Draeger Medical, Inc. NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) Open, Classified |
CBK | K081743 |
| Feb 24, 2023 | Draeger Medical, Inc. NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L) Open, Classified |
CBK | K081743 |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals Open, Classified |
CBK | K170037 |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals Open, Classified |
CBK | K170037 |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals Open, Classified |
CBK | K170037 |
| Feb 24, 2023 | Baxter Healthcare Corporation Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals Open, Classified |
CBK | K170037 |
| Jan 6, 2023 | Philips Respironics, Inc. Philips Garbin Ventilator, Model Number 1058180B Open, Classified |
CBK | K083526 |
| Jan 6, 2023 | Philips Respironics, Inc. Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B Open, Classified |
CBK | K093416 |
| Jan 6, 2023 | Philips 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 |
CBK | K083526 |
| Nov 18, 2022 | Hamilton Medical AG Hamilton-C6 Open, Classified |
CBK | K201658 |
| Jul 21, 2022 | Getinge 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 |
CBK | K192604 |
| Jul 20, 2022 | Getinge 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 |
CBK | K192604 K201874 |
| Jun 27, 2022 | Hamilton Medical AG HAMILTON-C6 Intensive Care Ventilator, REF: 160021 Open, Classified |
CBK | K201658 |
| Jun 6, 2022 | GE Healthcare, LLC Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators. Open, Classified |
CBK | K111116 K142679 |
| Jun 6, 2022 | GE 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 |
CBK | K111116 K142679 |
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