Skip to content

Primeaire

by Thayer Medical Corporation

510(k) K992722

Primeaire is a Class II device made by Thayer Medical Corporation, cleared under FDA 510(k) K992722 on 10 Nov 1999, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992722 Date10 Nov 1999ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CAF
FDA applicant
Thayer Medical Corp.
Device class
Class II
Regulation
21 CFR Part 868.5630
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K992722

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K992722
UDI-DISize and differences
PRIMEAIRE 1114
THAYER MEDICAL CORPORATION
1114 / 111400383480000051 —On the market

Other devices from Thayer Medical Corporation

See all devices from Thayer Medical Corporation →