Vivo 50
Continuous, Ventilator, Home Use
1manufacturer
17catalogue numbers in this listing
3510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Breas Medical, Inc., United States |
|---|---|
| FDA product code | NOU |
| Device type | Continuous, Ventilator, Home Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123144 |
| Record published | 2022-06-18 |
| Record revised | 2023-03-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box |
| Sizes | Length 10 to 50 m |
| Distribution end date | 2026-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 007219 | In distribution | |
| 004892 | Withdrawn | |
| 004896 | Length 10 m | Withdrawn |
| 005429 | Withdrawn | |
| 004897 | Length 25 m | Withdrawn |
| 005094 | Withdrawn | |
| 004891 | Withdrawn | |
| US | Withdrawn | |
| 004893 | Withdrawn | |
| US | Withdrawn | |
| 005928 | Withdrawn | |
| 005036 | Length 10 m | Withdrawn |
| 004894 | Withdrawn | |
| 005428 | Withdrawn | |
| US | Withdrawn | |
| 005223 | Length 25 m | Withdrawn |
| 004898 | Length 50 m | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Patient Circuit | Flight Medical Innovations Ltd. | 13 |
| Astral | Resmed PTY Ltd. | 12 |
| Trilogy Evo | Respironics Inc. | 10 |
| Trilogy | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 10 |
| Trilogy 200 | Respironics Inc. | 5 |
| Continuous Ventilator | Flight Medical Innovations Ltd. | 3 |
| Trilogy 100 | Respironics Inc. | 3 |
| Vocsn Roll Stand | Ventec Life Systems, Inc. | 2 |
| Sensor | Respironics Inc. | 2 |
| Astral Double Limb Kit | Resmed PTY Ltd. | 1 |
| Trilogy EV300 | Respironics Inc. | 1 |
Showing 12 of 28. All products under Continuous, Ventilator, Home Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233452 | 2025-01-13 |
| K193586 | 2021-01-27 |
| K160481 | 2016-11-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Breas Medical, Inc. | 510(k) number | 2014-11-07 | Class II | Device Design | Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipm | 846 US | 2016-04-07 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-07-25 | Class I | Under Investigation by firm | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. | 8298 | |
| 2023-10-13 | Class II | Process control | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation | 215 units | |
| 2022-06-02 | Class II | Device Design | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Perman | 1,113 units | |
| 2020-01-28 | Class II | Device Design | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. | 629 | 2020-09-15 |
| 2018-05-08 | Class III | Employee error | Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. | 45 | 2020-05-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.