Skip to content

STS

by Techbopulm, Ltd.

510(k) K240293

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240293 Date17 Sep 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
BZC
Device Class
Class II
Regulation
21 CFR Part 868.1880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 STS is a Calculator, Pulmonary Function Data device, classified under medical specialty Anesthesiology. It is a class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device was manufactured by Techbopulm, Ltd., with 510(k) number K240293, decision date 2024-09-17, and regulation number 868.1880. It was cleared via the traditional 510(k) pathway and reviewed by the Anesthesiology advisory committee.

Questions

AI-generated answers, 26 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 STS device used for?

    The STS is a calculator designed to process pulmonary function data, intended for use in anesthesiology to support clinical assessments of respiratory performance.

  • Who manufactures the STS device and what is its regulatory clearance?

    The STS is manufactured by Techbopulm, Ltd. and received FDA 510(k) clearance under number K240293 on September 17, 2024, as substantially equivalent to a predicate device.

  • What classification and pathway apply to the STS device?

    The STS is a class II medical device cleared through the traditional 510(k) pathway, with review conducted by the Anesthesiology advisory committee.