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Dideco-Shiley Universal Y

by Shiley, Inc. 510(k)

Active United States

510(k) K894294

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894294 Date15 Aug 1989ClearedStatusActive

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  • Withdrawn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
CAC
Device Class
Class II
Regulation
21 CFR Part 868.5830
Advisory Committee
Anesthesiology
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 Dideco-Shiley Universal Y is an apparatus for autotransfusion, designed to collect, process, and return a patient's own blood during surgical procedures. It facilitates the recovery of blood lost during surgery for reinfusion, reducing the need for donor blood transfusions.

This device is supplied as a Class II medical device with FDA 510(k) clearance (K894294) under product code CAC. It is intended for single-use in clinical settings, with specific storage requirements as per manufacturer guidelines. The device is authorized for use in anesthesiology applications and is MRI conditional, with various sizes available to accommodate different clinical needs.

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