Panels › Anesthesiology › Product code NOU · Class 2
Continuous, Ventilator, Home Use
Regulation 868.5895
0510(k)s in 12 months (7 all time)
1recalls in 12 months (16 all time)
12recalls that name a 510(k)
Top companies in NOU
| Company | 510(k)s | Recalls |
|---|---|---|
| Breas Medical AB | 3 | 5 |
| Philips Respironics, Inc. | 0 | 5 |
| Pulmonetic Systems, Inc. | 0 | 4 |
| Respironics California, Inc. | 2 | 0 |
| Ge Healthcare, Breas Medical AB | 1 | 0 |
| Human Design Medical Llc | 0 | 1 |
| Ventec Life Systems, Inc. | 0 | 1 |
| Versamed , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Ventec Life Systems, Inc. VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 Open, Classified |
NOU | K162877 |
| Sep 5, 2024 | Philips 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 |
NOU | K181170 |
| Sep 5, 2024 | Philips 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 |
NOU | K181170 |
| Sep 3, 2024 | Breas Medical, Inc. Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Open, Classified |
NOU | K193586 |
| Nov 27, 2023 | Breas Medical, Inc. with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS.
intended for partial insertion into a patient's mouth (in betw Open, Classified |
NOU | K193586 K233452 |
| Jun 2, 2022 | Breas Medical, Inc. Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Model Number: 230000
If the recalled product Open, Classified |
NOU | K193586 |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B Open, Classified |
NOU | K181166 |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, R Open, Classified |
NOU | K181166 |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR211 Open, Classified |
NOU | K181166 |
| Jan 28, 2020 | Breas Medical, Inc. Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended Terminated |
NOU | K160481 |
| May 8, 2018 | Human Design Medical Llc Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000
Product Usage:
To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Terminated |
NOU | K160481 |
| Jul 16, 2015 | Breas Medical AB Breas Vivo 50 Home Care Ventilator
Product Usage:
Respiratory Care Terminated |
NOU | K123144 |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 1000 with either part # 10134 or Terminated |
NOU | None listed |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 900 with either part # 10134 or 1 Terminated |
NOU | None listed |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 1 Terminated |
NOU | None listed |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or Terminated |
NOU | None listed |
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