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IV Start Kit

by Cypress Medical Products, Ltd.

510(k) K914475

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)SEKD Traditional NumberK914475 Date18 Mar 1992ClearedStatusActive

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  • Withdrawn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
LRS
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SEKD

Overview

AI-generated summary, 1 Oct 2026

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

The IV Start Kit is a sterile, single-use medical device designed for initiating intravenous (IV) access. It includes components such as a catheter, adhesive dressing, and a prefilled sodium chloride syringe for flushing the catheter, facilitating quick and effective venous cannulation in clinical settings.

This kit is intended for use in hospital environments and is supplied as a sterile, single-use product. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K914475). The kit is not MRI-safe and must be stored in a clean, dry environment until use, adhering to standard sterile medical device protocols.

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Questions

AI-generated answers, 1 Oct 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 IV Start Kit designed for?

    The IV Start Kit is specifically designed to initiate intravenous (IV) access in clinical settings. It includes a catheter, adhesive dressing, and a prefilled sodium chloride syringe for flushing the catheter, making it ideal for quickly and effectively establishing venous cannulation in hospital environments.

  • Is the IV Start Kit sterile and single-use?

    Yes, the IV Start Kit is both sterile and intended for single-use only. This ensures patient safety and reduces the risk of contamination or infection during IV insertion.

  • How should the IV Start Kit be stored?

    The kit must be stored in a clean, dry environment until use. Adhering to standard sterile medical device protocols is essential to maintain its integrity and ensure safe clinical use.

  • Can the IV Start Kit be used in MRI environments?

    No, the IV Start Kit is not MRI-safe. If MRI procedures are required for the patient, the kit must be removed before imaging begins.

  • What components are included in the IV Start Kit?

    The kit includes a catheter for insertion, an adhesive dressing to secure the catheter in place, and a prefilled sodium chloride syringe for flushing the catheter to ensure proper patency before use.