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Avea 463711

by Vyaire Medical, Inc.

Avea 463711 is a Class II device made by Vyaire Medical, Inc., cleared under FDA 510(k) K942211 on 22 Nov 1994 and listed in FDA GUDID since 12 Mar 2021 (UDI-DI 10190752162549), 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) K942211

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 Number10190752162549 UDI-DI Date12 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK942211 Date22 Nov 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K942211 decided 22 Nov 1994 Active
  • FDA GUDID UDI-DI 10190752162549 listed 12 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K942211
  2. Listed FDA GUDID 10190752162549

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Avea
Generic name
Neonatal/adult intensive-care ventilator
Model / Ref / Catalog
463711
Primary DI / UDI-DI
10190752162549
510(k) Number
FDA product code
BTY
GMDN term
Neonatal/adult intensive-care ventilator
Device class
Class II
Regulation number
868.1890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neonatal/adult intensive-care ventilator

Cleared under the same submission (K942211)

and 8 more cleared under K942211

Similar devices in this category

Other devices filed under Neonatal/adult intensive-care ventilator.

Other devices from Vyaire Medical, Inc.

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See all devices from Vyaire Medical, Inc. →

Properties

  • Manufacturing date
Other properties (14, all answered No)