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Vyaire V-375610

by Jaeger Medical GmbH

Vyaire V-375610 is a Class II device made by Jaeger Medical GmbH, cleared under FDA 510(k) K150810 on 14 Aug 2015 and listed in FDA GUDID since 18 Feb 2020 (UDI-DI 34250892905816), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K150810

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number34250892905816 UDI-DI Date18 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150810 Date14 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150810 decided 14 Aug 2015 Active
  • FDA GUDID UDI-DI 34250892905816 listed 18 Feb 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1730-2024 FDA Class I initiated 8 Apr 2024

    Potential of the nozzle separating during patient use.

Timeline

3 dated events

  1. Cleared FDA 510(k) K150810
  2. Listed FDA GUDID 34250892905816
  3. Recall initiated FDA recalls Z-1730-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vyaire
Generic name
Electrocardiography telemetric monitoring system transmitter
Model / Ref / Catalog
V-375610
Primary DI / UDI-DI
34250892905816
510(k) Number
FDA product code
BZC
GMDN term
Electrocardiography telemetric monitoring system transmitter
Device class
Class II
Regulation number
868.1880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiography telemetric monitoring system transmitter

Cleared under the same submission (K150810)

and 8 more cleared under K150810

Similar devices

Other devices filed under FDA product code BZC (Calculator, Pulmonary Function Data).

Other devices from Jaeger Medical GmbH

See all devices from Jaeger Medical GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)