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Spiromate AS-500

by Riko Medical & Scientific Instrument Corp.

510(k) K842372

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842372 Date26 Jun 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
BZG
Device Class
Class II
Regulation
21 CFR Part 868.1840
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Spiromate AS-500 is a diagnostic spirometer classified under FDA class 2. It is a substantially equivalent device cleared through the traditional 510(k) pathway, with product code BZG and regulation number 868.1840. The device is intended for use in the field of anesthesiology, as indicated by its medical specialty designation.

Manufactured by Riko Medical & Scientific Instrument Corp., the Spiromate AS-500 received FDA clearance on June 26, 1984, under K number K842372. It is supplied as a non-sterile, reusable diagnostic instrument for pulmonary function testing. No information regarding sterility, single-use status, MRI safety, sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance is provided in the data.

Other devices from Riko Medical & Scientific Instrument Corp.

Questions

AI-generated answers, 25 Sep 2026

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

  • What is the Spiromate AS-500 used for?

    The Spiromate AS-500 is a diagnostic spirometer intended for pulmonary function testing in the field of anesthesiology, as indicated by its medical specialty designation and FDA classification under product code BZG and regulation number 868.1840.

  • Is the Spiromate AS-500 sterile or single-use?

    The Spiromate AS-500 is supplied as a non-sterile, reusable diagnostic instrument, meaning it is not provided sterile and is designed for multiple uses after appropriate cleaning and reprocessing by the user.

  • How was the Spiromate AS-500 cleared for market?

    The Spiromate AS-500 received FDA clearance through the traditional 510(k) pathway as a substantially equivalent device, with clearance granted on June 26, 1984, under K number K842372, based on its equivalence to a legally marketed predicate device.