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Disposable Infusion Set

by Ks Medical Supply Co. 510(k)

Active United States

510(k) K780559

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780559 Date6 Jun 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
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.

This device is a Disposable Infusion Set, classified under product code FPA, designed for single-use administration of fluids or medications intravenously. It consists of tubing, connectors, and a needle or catheter intended to deliver solutions directly into a patient’s bloodstream, ensuring controlled and sterile delivery.

The set is supplied as a sterile, single-use disposable item, intended for use in general hospital settings. It requires no special storage conditions beyond standard cleanroom practices and is regulated under FDA 510(k) clearance (K780559) as substantially equivalent to prior-generation devices. Compliance with ISO 13485 and EU MDR 2017/745 may apply depending on regional distribution, though no explicit CE marking or additional regulatory status is stated in the provided data.