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500326-100

by Benson Medical Instruments Co.

500326-100, a breathing mouthpiece (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Benson Medical Instruments Co., was cleared under FDA 510(k) K123896 on 10 Sep 2013 and listed in FDA GUDID on 22 Oct 2016 (UDI-DI B207500326100); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K123896

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 NumberB207500326100 UDI-DI Date22 Oct 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123896 Date10 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123896 decided 10 Sep 2013 Active
  • FDA GUDID UDI-DI B207500326100 listed 22 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123896
  2. Listed FDA GUDID B207500326100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Breathing mouthpiece, single-use
Model / Ref / Catalog
500326-100
Primary DI / UDI-DI
B207500326100
510(k) Number
FDA product code
BZG
GMDN term
Breathing mouthpiece, single-use
Device class
Class II
Regulation number
868.1840
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K123896)

Similar devices

Other devices filed under FDA product code BZG (Spirometer, Diagnostic).

Other devices from Benson Medical Instruments Co.

See all devices from Benson Medical Instruments Co. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)