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Spiro Handle

by Bionet Co., Ltd.

Spiro Handle is a diagnostic spirometer (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Bionet Co., Ltd., cleared under FDA 510(k) K130322 on 15 Nov 2013 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 08809276943729), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K130322

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809276943729 UDI-DI Date15 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130322 Date15 Nov 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130322 decided 15 Nov 2013 Active
  • FDA GUDID UDI-DI 08809276943729 listed 15 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130322
  2. Listed FDA GUDID 08809276943729

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Diagnostic spirometer, professional
Model / reference
Spiro Handle
Primary DI / UDI-DI
08809276943729
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
MRI safety
MR Unsafe

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Category: Diagnostic spirometer, professional

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)