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Laserflo Blood Perfusion Monitor BPM403A

by Tsi, Inc.

510(k) K875179

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 NumberK875179 Date19 Sep 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Modified Laserflo Blood Perfusion Monitor, BPM403A
510(k) Number
FDA Product Code
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Laserflo Blood Perfusion Monitor BPM403A is a flowmeter, blood, cardiovascular device designed to measure microvascular blood volume, velocity, and flow. It provides quantitative assessment of tissue perfusion by utilizing laser Doppler technology to detect and analyze blood flow characteristics in real-time. This enables clinicians to evaluate circulatory function, particularly in microvascular beds, for diagnostic or monitoring purposes.

The device is supplied as a reusable medical instrument intended for use in clinical settings, including cardiovascular monitoring. It operates without requiring sterility for each use but must be cleaned and maintained according to manufacturer guidelines. The BPM403A is classified under FDA regulation 870.2100 and holds a 510(k) clearance (K875179) for substantial equivalence. No specific MRI safety or single-use designation is indicated in the regulatory data.

Other devices from Tsi, Inc.

Questions

AI-generated answers, 20 Sep 2026

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

  • How is the Laserflo Blood Perfusion Monitor BPM403A intended to be used in clinical settings, and what does it measure?

    The Laserflo Blood Perfusion Monitor BPM403A is a reusable cardiovascular device designed to measure microvascular blood volume, velocity, and flow in real-time using laser Doppler technology. It provides quantitative assessment of tissue perfusion, enabling clinicians to evaluate circulatory function—particularly in microvascular beds—during diagnostic or monitoring procedures.

  • Is the Laserflo Blood Perfusion Monitor BPM403A a single-use or reusable device, and what cleaning requirements apply?

    The BPM403A is a reusable medical instrument and does not require sterility for each use. However, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper function and hygiene between uses.

  • What regulatory pathway was followed for FDA clearance of the Laserflo Blood Perfusion Monitor BPM403A, and what classification does it hold?

    The BPM403A received FDA clearance through a 510(k) submission (K875179) under the Traditional clearance type, demonstrating substantial equivalence to a predicate device. It is classified under FDA regulation 870.2100 as a Class II flowmeter for blood, cardiovascular use, as indicated by the DPW product code.

  • Can this device be used in conjunction with MRI procedures, or are there any MRI safety considerations?

    The provided regulatory data does not specify MRI safety information for the Laserflo Blood Perfusion Monitor BPM403A, so its compatibility with MRI environments cannot be confirmed. Clinicians should consult the manufacturer’s instructions or safety guidelines before use in MRI settings.