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Provider IV. Model 5000 Infusion Device

by Pancretec, Inc.

510(k) K871806

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 NumberK871806 Date22 Oct 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  • Withdrawn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)

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, 23 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 Provider IV. Model 5000 Infusion Device is an infusion pump used in a health care facility. It is classified as a Class 2 General Hospital device.

This device is regulated under FDA 510(k) clearance K871806. It is a traditional 510(k) submission manufactured by Pancretec, Inc.

Other devices from Pancretec, Inc.

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Questions

AI-generated answers, 23 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 use of the Provider IV. Model 5000?

    The Provider IV. Model 5000 is an infusion pump intended for use within a health care facility to assist in the delivery of fluids or medications.

  • How is this device regulated?

    This device is classified as a Class 2 General Hospital device and is regulated under FDA 510(k) clearance number K871806, which was granted following a traditional 510(k) submission.

  • Who is the manufacturer of this infusion pump?

    The Provider IV. Model 5000 Infusion Device is manufactured by Pancretec, Inc., located in San Diego, California.