Skip to content

Infusomat P

by B. Braun Medical, Inc.

510(k) K003029

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003029 Date4 Dec 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 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  • Withdrawn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
FRN
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5725
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Infusomat P is a pump, infusion, as classified by the device type. It is designed to provide volumetric infusion solutions.

The Infusomat P is supplied with various pump sets and is intended for use in a general hospital setting. It has been cleared by the FDA under the product code FRN and regulation number 880.5725, with a device class of 2.

From the manufacturer

Infusomat® Space® Pump Sets -. B. Braun pump sets offer comprehensive standard and Design Options ® lines of disposables, integrating easily into clinical requirements and allowing quicker therapy starts.

Source: bbraunusa.com

Other devices from B. Braun Medical, Inc.

See all devices from B. Braun Medical, Inc. →

Questions

AI-generated answers, 28 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 Infusomat P used for?

    The Infusomat P is used to provide volumetric infusion solutions in a general hospital setting, offering accurate and reliable delivery of fluids and medications.

  • Is the Infusomat P supplied with pump sets?

    Yes, the Infusomat P is supplied with various pump sets to facilitate its use in different clinical applications.

  • What is the regulatory status of the Infusomat P?

    The Infusomat P has been cleared by the FDA under the product code FRN and regulation number 880.5725, with a device class of 2, indicating its substantial equivalence to existing devices.