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Taky-Spike Plus

by Clinico

510(k) K974198

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 NumberK974198 Date22 Dec 1997ClearedStatusActive

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  • Withdrawn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
LHI
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.

The Taky-Spike Plus is a withdrawal cannula (Product Code: LHI) designed for sterile liquid transfer between syringes and vials. It incorporates a hydrophobic membrane to facilitate air exchange while preventing contamination of vial or syringe contents and minimizing aerosol escape of liquid.

This device is intended for use in general hospital settings and is supplied as a single-use item. The FDA granted Traditional 510(k) clearance (K974198) under the Substantially Equivalent determination, classifying it as a Class 2 device. No additional regulatory markings (e.g., MRI safety, sterility beyond sterile packaging) are specified in the submitted data.

Other devices from Clinico

Questions

AI-generated answers, 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.

  • What is the Taky-Spike Plus primarily used for in a hospital setting?

    The Taky-Spike Plus is designed specifically for sterile liquid transfer between syringes and vials. Its hydrophobic membrane allows controlled air exchange during the process while preventing contamination of the vial or syringe contents and reducing aerosol escape of liquid, making it ideal for precise medication handling in general hospital procedures.

  • Is the Taky-Spike Plus intended for reuse, or is it meant to be used only once?

    The Taky-Spike Plus is explicitly supplied as a single-use item. This design ensures sterility and safety for each procedure, preventing cross-contamination between patients or uses.

  • How is the Taky-Spike Plus packaged, and does it come sterile?

    The device is supplied in sterile packaging, which is standard for single-use medical items like this. The packaging ensures the hydrophobic membrane and cannula remain uncontaminated until first use.

  • What regulatory pathway was followed for the FDA clearance of the Taky-Spike Plus?

    The Taky-Spike Plus received Traditional 510(k) clearance (K974198) under the Substantially Equivalent determination, classifying it as a Class 2 device. This means it was compared to a legally marketed predicate device to demonstrate safety and effectiveness before approval.

  • Are there different sizes or models available for the Taky-Spike Plus?

    The provided data does not specify variations in sizes or models for the Taky-Spike Plus. It is described as a single product designed for general hospital use, so additional sizing or model options would need to be confirmed directly with Clinico.