Skip to content

Bach-Simpson Model TS266

by Bach-Simpson, Ltd.

510(k) K811616

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 NumberK811616 Date13 Aug 1981ClearedStatusActive

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  • Withdrawn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
DPW
FDA applicant
Bach-Simpson , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a blood flowmeter classified under cardiovascular medical specialty. It is a substantially equivalent device cleared via the traditional 510(k) pathway.

It is supplied by Bach-Simpson, Ltd. and is authorized under FDA 510(k) K811616. The device is intended for use in cardiovascular applications and is regulated as a Class II medical device.

Other devices from Bach-Simpson, Ltd.

Questions

AI-generated answers, 1 Oct 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 Bach-Simpson Model TS266 used for?

    The Bach-Simpson Model TS266 is a blood flowmeter intended for use in cardiovascular applications, as specified in its FDA 510(k) clearance, to measure blood flow during diagnostic or monitoring procedures in the cardiovascular system.

  • How is the Bach-Simpson Model TS266 supplied and is it sterile or reusable?

    The device is supplied by Bach-Simpson, Ltd., but the provided data does not specify whether it is sterile, single-use, or reusable; therefore, no conclusion can be drawn about its sterility or reuse status from the available information.

  • What regulatory pathway cleared the Bach-Simpson Model TS266 and what is its classification?

    The Bach-Simpson Model TS266 was cleared via the traditional FDA 510(k) pathway under K811616 and is regulated as a Class II medical device, as indicated by its decision description and device class in the OpenFDA data.