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Verifuse Ambulatory Pump

by Block Medical, Inc. 510(k)

Active United States

510(k) K902891

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902891 Date21 Nov 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
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 Verifuse Ambulatory Pump is an infusion pump device designed for ambulatory use. It is classified as a Pump, Infusion and is intended for general hospital settings.

The device is manufactured by Block Medical, Inc. and has FDA 510(k) clearance with the number K902891. It is regulated under product code FRN and regulation number 880.5725. The device is substantially equivalent to predicate devices and is available in various models as indicated by the registration numbers provided.

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