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SPM-300 Spirometer

by Bionet Co., Ltd.

510(k) K130322

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 NumberK130322 Date15 Nov 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Spm-300
510(k) Number
FDA product code
BZG
Device class
Class II
Regulation
21 CFR Part 868.1840
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SPM-300 is a diagnostic spirometer designed to measure lung function parameters, including forced expiratory volume and vital capacity. It is classified as a Class II medical device and used for assessing respiratory health in clinical settings.

This device operates with disposable sensors, eliminating the need for disinfection between uses. Supplied as a reusable diagnostic tool, it is intended for use in general practice, specialty physician offices, and hospitals. The SPM-300 holds an FDA 510(k) clearance under the Anesthesiology advisory committee and adheres to regulation 868.1840.

Devices cleared under K130322

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 K130322
UDI-DISize and differences
Spiro Handle
Bionet Co., Ltd.
Spiro Handle08809276943729 —On the market

Similar devices

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

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