Who else makes this device?

Name: Vyntus
Brand: Vyntus

Vyntus · Calculator, Pulmonary Function Data → Anesthesiology

1manufacturer

3catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BZC
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77

Record

Regulatory record for Vyntus
Listed by	Vyaire Medical, Inc., United States
FDA product code	BZC
Device type	Calculator, Pulmonary Function Data
Device class	Class 2
Regulation	21 CFR 868.1880
510(k)	K150810
Record published	2021-04-09
Record revised	2025-09-24 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Special storage condition: Keep Dry

Catalogue Numbers

Catalogue numbers for Vyntus
Catalogue number	Size	Status
V-707356		In distribution
V-178604		In distribution
V-378510		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Jaeger	Jaeger Medical GmbH	227
Vyaire	Jaeger Medical GmbH	120
Vyntus	Jaeger Medical GmbH	14
Innocor	Innovision Medical Technologies, LLC	6
Cosmed	C O S M E D SRL	3
APS-Pro SA	Jaeger Medical GmbH	3
MGC Diagnostics	Medical Graphics Corp.	2
TransAir3	Medi Soft SA	1
MasterScreen PFT	Jaeger Medical GmbH	1
Respiratory Mechanics Sensor → Neonatal	Draeger Medical Systems, Inc.	1
SentrySuite Software	Jaeger Medical GmbH	1
TrueOne 2400	Parvomedics, Incorporated	1

Showing 12 of 19. All products under Calculator, Pulmonary Function Data

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183567	2019-08-23
K190853	2019-08-16
K181524	2018-11-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Vyntus
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Jaeger Medical GmbH	510(k) number	2024-04-08	Class I	Process control	Potential of the nozzle separating during patient use.	649 devices

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.

Vyntus