Syringe Pump MS2000

by Smash Ent., Inc.

510(k) K880857

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K880857↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK880857	Date1 Sep 1988Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K880857
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, 21 Sep 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 syringe pump, specifically the MS2000 model, classified as an infusion pump under device class II. It is designed for the controlled delivery of fluids in a clinical setting.

The SYRINGE PUMP MS2000 is supplied as a reusable device intended for use in general hospital environments. It received FDA 510(k) clearance under K880857 on September 1, 1988, and is substantially equivalent to a legally marketed predicate device.