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Solution Administration Set

by Distronic Sterile Products, Inc. 510(k)

Active United States

510(k) K952664

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952664 Date7 Aug 1995ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

A solution administration set is a device used for delivering fluids to a patient. It is designed to connect fluid containers to vascular access devices for the administration of solutions.

This set is supplied sterile and intended for single-use. It is used in general hospital settings and has received FDA 510(k) clearance under product code FPA, with clearance granted on August 7, 1995.

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