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Chemo-Spike II Reconstitution Device

by Medi-Dose, Inc.

510(k) K974431

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 NumberK974431 Date8 Jan 1998ClearedStatusActive

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  • Withdrawn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 Chemo-Spike II Reconstitution Device is a medical device classified as a reconstitution and dispensing accessory for chemotherapy. It is designed to facilitate the aseptic preparation of lyophilized chemotherapy drugs stored in multiple-dose vials by enabling controlled addition of diluent or withdrawal of medication.

This device is intended for use in hospital settings by trained medical personnel performing aseptic procedures. Supplied as a single-use item, it requires no special regulatory classification beyond its FDA 510(k) clearance (K974431). No MRI safety or sterility specifications beyond standard aseptic handling are noted in the data.

Other devices from Medi-Dose, Inc.

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 Chemo-Spike II Reconstitution Device used for in a clinical setting?

    The Chemo-Spike II Reconstitution Device is designed specifically for aseptic preparation of lyophilized chemotherapy drugs stored in multiple-dose vials. It allows trained medical personnel to safely add diluent or withdraw medication in a controlled manner, reducing the risk of contamination during reconstitution in hospital settings.

  • Is the Chemo-Spike II Reconstitution Device intended for single-use or can it be reused?

    The Chemo-Spike II Reconstitution Device is explicitly supplied as a single-use item. This design ensures aseptic integrity and minimizes the risk of cross-contamination between patients or procedures, aligning with best practices for chemotherapy handling.

  • How is the Chemo-Spike II Reconstitution Device regulated, and what does that mean for its use?

    The device holds an FDA 510(k) clearance (K974431) under the Traditional clearance type, determined as substantially equivalent to a predicate device. This means it has undergone regulatory review to confirm its safety and effectiveness for its intended use as a reconstitution accessory in chemotherapy preparation, ensuring compliance with U.S. medical device regulations.

  • What type of healthcare environment is the Chemo-Spike II Reconstitution Device intended for?

    The device is intended for use in hospital settings, specifically by trained medical personnel performing aseptic procedures. Its design and regulatory classification (General Hospital product code) reflect its role in controlled, high-stakes environments where chemotherapy preparation must adhere to strict sterility and safety protocols.