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Model 2000 Ambulatory Infuser

by Parker Hannifin Corp.

510(k) K863532

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863532 Date14 Jan 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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 Labeling to Model 2000 Ambulatory Infuser
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, 22 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 Model 2000 Ambulatory Infuser is an infusion pump designed for the delivery of fluids. It functions as a medical device intended for use in general hospital settings.

This device is regulated as a Class II medical device under FDA 510(k) clearance K863532. It is identified by product code FRN and regulation number 880.5725.

Other devices from Parker Hannifin Corp.

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Questions

AI-generated answers, 22 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 primary function of the Model 2000 Ambulatory Infuser?

    The Model 2000 is an infusion pump specifically designed for the delivery of fluids. It is intended for use within general hospital settings to assist clinical staff with fluid management.

  • What is the regulatory classification of this device?

    This device is regulated as a Class II medical device under FDA 510(k) clearance K863532. It is categorized under product code FRN and regulation number 880.5725.

  • Who is the manufacturer of this infusion pump?

    The Model 2000 Ambulatory Infuser is manufactured by Parker Hannifin Corp., located in Irvine, California.