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Syringe Tip Adaptor

by Acacia, Inc.

510(k) K894217

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 NumberK894217 Date12 Sep 1989ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Syringe Tip Adaptor is a medical device designed to facilitate the transfer of fluids between various medical components. It serves as a connector for syringes, allowing for compatibility with large fill syringes, repeating syringes, or luer connection pump tube sets.

This device is classified as a Class 2 General Hospital device and has received FDA 510(k) clearance under K894217. It is manufactured by Acacia, Inc. and was determined to be substantially equivalent through the traditional 510(k) pathway.

Other devices from Acacia, Inc.

See all devices from Acacia, Inc. →

Questions

AI-generated answers, 24 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 primary function of the Syringe Tip Adaptor?

    The Syringe Tip Adaptor is designed to facilitate the transfer of fluids between medical components. It acts as a connector that allows syringes to be compatible with large fill syringes, repeating syringes, or luer connection pump tube sets.

  • What is the regulatory status of this device?

    This device has received FDA 510(k) clearance under K894217. It was determined to be substantially equivalent to existing devices through the traditional 510(k) pathway and is classified as a Class 2 General Hospital device.

  • Who is the manufacturer of the Syringe Tip Adaptor?

    The Syringe Tip Adaptor is manufactured by Acacia, Inc., located in Loma Linda, California.