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Syringe Infusion Pump

by Princeton Medical Instruments, Inc.

510(k) K791729

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 NumberK791729 Date1 Oct 1979ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A syringe infusion pump is a device designed to deliver fluids in a controlled and precise manner by mechanically advancing the plunger of a syringe. It is classified as a Class II medical device under the FDA's general hospital medical specialty category.

This device received FDA 510(k) clearance (K791729) on October 1, 1979, as substantially equivalent to a legally marketed predicate device. It is supplied as a reusable or single-use component depending on configuration, intended for use in general hospital settings, and does not have stated MRI safety, sterility, or size specifications in the provided data.

Other devices from Princeton Medical Instruments, Inc.

Questions

AI-generated answers, 19 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 syringe infusion pump designed to do?

    The syringe infusion pump is designed to deliver fluids in a controlled and precise manner by mechanically advancing the plunger of a syringe, enabling accurate fluid administration in clinical settings.

  • How is the syringe infusion pump supplied in terms of reuse?

    The device is supplied as either reusable or single-use depending on its specific configuration, allowing flexibility based on clinical needs and institutional protocols for cleaning and sterilization.

  • What regulatory pathway was used for the syringe infusion pump's market authorization?

    The syringe infusion pump received FDA 510(k) clearance under submission K791729 on October 1, 1979, as substantially equivalent to a legally marketed predicate device, following the traditional 510(k) review process.

  • In what type of setting is the syringe infusion pump intended for use?

    The device is intended for use in general hospital settings, as indicated by its classification under the FDA's general hospital medical specialty category and its advisory committee designation of HO (Hospital).

  • Does the provided data specify whether the syringe infusion pump is sterile or has MRI safety information?

    No, the provided data does not include any information regarding sterility or MRI safety for the syringe infusion pump; these characteristics are not stated in the device specifications or authorization details.