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MIR MiniSpir PLUS

by Mir Medical International Research SpA 2 variants

MIR MiniSpir PLUS is an expiratory peak flow meter (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Mir Medical International Research SpA, cleared under FDA 510(k) K122384 on 4 Oct 2012 and listed in FDA GUDID since 25 Nov 2024 (UDI-DI 08052990320424), 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) K122384

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 Number08052990320424 UDI-DI Date25 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK122384 Date4 Oct 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122384 decided 4 Oct 2012 Active
  • FDA GUDID UDI-DI 08052990320424 listed 25 Nov 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122384
  2. Listed FDA GUDID 08052990320424

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mir
Generic name
Expiratory peak flow meter, digital
Model / reference
MiniSpir PLUS
Primary DI / UDI-DI
08052990320424
510(k) Number
FDA product code
BZG
GMDN term
Expiratory peak flow meter, digital
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Expiratory peak flow meter, digital

Cleared under the same submission (K122384)

and 8 more cleared under K122384

Similar devices in this category

Other devices filed under Expiratory peak flow meter, digital.

Other devices from Mir Medical International Research SpA

See all devices from Mir Medical International Research SpA →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)