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Serial Flow

by Spirometrics, Inc.

510(k) K900673

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 NumberK900673 Date3 Apr 1990ClearedStatusActive

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  • Withdrawn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, 21 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 Serial Flow is a diagnostic spirometer used to measure respiratory function. It is designed to assess airflow and lung performance in clinical settings.

This device is manufactured by Spirometrics, Inc. and has received FDA 510(k) clearance under K900673. It is classified as a Class 2 medical device under regulation number 868.1840.

Other devices from Spirometrics, Inc.

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Questions

AI-generated answers, 21 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 primary purpose of the Serial Flow device?

    The Serial Flow is a diagnostic spirometer designed to measure respiratory function. It is used by clinicians to assess airflow and overall lung performance in a clinical setting.

  • Has this device received regulatory clearance?

    Yes, the Serial Flow has received FDA 510(k) clearance under submission number K900673. It is classified as a Class 2 medical device under regulation number 868.1840.

  • Who is the manufacturer of the Serial Flow?

    The Serial Flow is manufactured by Spirometrics, Inc., located in Auburn, Maine.