Skip to content

Infusion Pump

by Air-Shields, Inc.

510(k) K780503

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 NumberK780503 Date10 Apr 1978ClearedStatusActive

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  • Withdrawn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, 25 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 Infusion Pump is a medical device designed for the controlled administration of fluids, medications, or nutrients into a patient's body. It operates by delivering precise amounts of substances at specific rates, ensuring accurate dosing and consistent treatment delivery.

This device is intended for use in hospital settings and is supplied as a reusable unit. It is not MRI compatible and requires appropriate storage conditions. The Infusion Pump has received FDA 510(k) clearance with the product code FRN and is classified as a Class II medical device.

Other devices from Air-Shields, Inc.

See all devices from Air-Shields, Inc. →

Questions

AI-generated answers, 25 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 Infusion Pump used for?

    The Infusion Pump is designed for the controlled administration of fluids, medications, or nutrients into a patient's body, ensuring accurate dosing and consistent treatment delivery in hospital settings.

  • Is the Infusion Pump single-use or reusable?

    The Infusion Pump is supplied as a reusable unit, meaning it can be used multiple times after appropriate cleaning and sterilization according to the manufacturer's instructions.

  • What is the regulatory status of this Infusion Pump?

    The Infusion Pump has received FDA 510(k) clearance with product code FRN and is classified as a Class II medical device, making it substantially equivalent to other devices on the market.

  • Is the Infusion Pump MRI compatible?

    No, the Infusion Pump is not MRI compatible and should not be used in MRI environments due to potential interference with the magnetic field.