Skip to content

Vyaire 36-ML2525-STK

by Jaeger Medical GmbH

Vyaire 36-ML2525-STK is a Class II device made by Jaeger Medical GmbH, cleared under FDA 510(k) K031102 on 1 Dec 2003 and listed in FDA GUDID since 19 Mar 2019 (UDI-DI 54250892905452), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K031102

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 Number54250892905452 UDI-DI Date19 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031102 Date1 Dec 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031102 decided 1 Dec 2003 Active
  • FDA GUDID UDI-DI 54250892905452 listed 19 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031102
  2. Listed FDA GUDID 54250892905452

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  • Withdrawn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
Diagnostic spirometer, professional
Model / Ref / Catalog
36-ML2525-STK
Primary DI / UDI-DI
54250892905452
510(k) Number
FDA product code
BZG
GMDN term
Diagnostic spirometer, professional
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Diagnostic spirometer, professional.

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)