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Ems I.V. Start Kit

by Emergency Medical Supply, Inc.

510(k) K951167

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)SN Traditional NumberK951167 Date16 May 1995DecidedStatusActive

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  • Withdrawn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
SN

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.

An I.V. Start Kit is a device used to initiate intravenous access. It includes components such as an IV extension set, prefilled saline flush syringe, and 8-ply gauze sponges necessary for safe and effective IV insertion.

The kit is supplied as a ready-to-use package for emergency medical service professionals. It is intended for use in general hospital settings and is classified as a Class II medical device under regulation number 880.5200 with product code LRS. The device received FDA 510(k) clearance (K951167) on May 16, 1995, and is substantially equivalent for some indications.

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 EMS I.V. START KIT used for?

    The EMS I.V. START KIT is used to initiate intravenous access. It contains components necessary for safe and effective IV insertion, including an IV extension set, prefilled saline flush syringe, and 8-ply gauze sponges, and is intended for use in general hospital settings by emergency medical service professionals.

  • How is the EMS I.V. START KIT supplied and is it ready to use?

    The EMS I.V. START KIT is supplied as a ready-to-use package, meaning all necessary components are pre-assembled and included in the kit for immediate use by emergency medical service professionals without additional preparation.

  • What components are included in the EMS I.V. START KIT?

    The EMS I.V. START KIT includes an IV extension set, a prefilled saline flush syringe, and 8-ply gauze sponges, which are the necessary components for safe and effective intravenous access initiation as described in the device description.

  • Is the EMS I.V. START KIT intended for single-use or reuse?

    Although the device data does not explicitly state single-use or reuse, the kit is supplied as a ready-to-use package for emergency medical service professionals and contains sterile components like a prefilled saline flush syringe and gauze sponges, which are typically intended for single-use in IV insertion procedures to maintain sterility and prevent cross-contamination.

  • What regulatory pathway was used for the EMS I.V. START KIT and what is its classification?

    The EMS I.V. START KIT received FDA 510(k) clearance (K951167) on May 16, 1995, and is classified as a Class II medical device under regulation number 880.5200 with product code LRS, indicating it went through the traditional 510(k) pathway for market authorization.