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Vyaire V-707708

by Jaeger Medical GmbH 2 variants

Vyaire V-707708 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 3 Jan 2023 (UDI-DI 14250892906352), 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 Number14250892906352 UDI-DI Date3 Jan 2023ListedStatusListed 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 14250892906352 listed 3 Jan 2023 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 14250892906352
  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  • Withdrawn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
Cardiopulmonary stress exercise monitoring system
Model / Ref / Catalog
V-707708
Primary DI / UDI-DI
14250892906352
510(k) Number
FDA product code
BZC
GMDN term
Cardiopulmonary stress exercise monitoring system
Device class
Class II
Regulation number
868.1880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiopulmonary stress exercise monitoring system

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

  • Lot / batch number
Other properties (14, all answered No)