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Ivac(R) Space.saver(Tm) Volumetric Pump Model 599

by Y

510(k) K894037

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 NumberK894037 Date28 Aug 1989ClearedStatusActive

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  • Withdrawn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, 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.

The Ivac Space Saver Volumetric Pump Model 599 is a pump, infusion device. It is classified as a Class 2 device with the product code FRN. The device is used for infusion purposes in a general hospital setting.

The device is supplied by Y and has been cleared by the FDA with the 510(k) number K894037. It is a non-single use device, and its regulation number is 880.5725. The device was cleared on August 28, 1989.

Other devices from Y

See all devices from Y →

Questions

AI-generated answers, 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.

  • What is the Ivac Space Saver Volumetric Pump Model 599 used for?

    The Ivac Space Saver Volumetric Pump Model 599 is used for infusion purposes in a general hospital setting.

  • Is the Ivac Space Saver Volumetric Pump Model 599 a single-use device?

    No, the Ivac Space Saver Volumetric Pump Model 599 is a non-single use device.

  • What is the regulatory classification of the Ivac Space Saver Volumetric Pump Model 599?

    The Ivac Space Saver Volumetric Pump Model 599 is classified as a Class 2 device with the product code FRN and regulation number 880.5725.