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Neo-Care Dual Lumen Umbilical Catheter

by Klein-Baker Medical, Inc.

510(k) K963972

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 NumberK963972 Date24 Dec 1996ClearedStatusActive

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  • Withdrawn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
FOS
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Neo-Care Dual Lumen Umbilical Catheter is a catheter, umbilical artery device. It is designed for use in a general hospital setting. The device has a dual lumen design and is used for umbilical catheterization. It is classified as a class 2 device.

The Neo-Care Dual Lumen Umbilical Catheter is supplied with an FDA 510K clearance, K963972. It has a product code of FOS and is regulated under regulation number 880.5200. The device is intended for single use and is provided in various sizes. It is stored at room temperature and is designed for use in a medical setting, specifically in general hospitals.

Other devices from Klein-Baker Medical, Inc.

Questions

AI-generated answers, 28 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 Neo-Care Dual Lumen Umbilical Catheter used for?

    The Neo-Care Dual Lumen Umbilical Catheter is used for umbilical catheterization in a general hospital setting, providing a dual lumen design for medical procedures.

  • Is the Neo-Care Dual Lumen Umbilical Catheter supplied sterile?

    The description does not explicitly state that the device is supplied sterile, but it is intended for single use and stored at room temperature.

  • What sizes is the Neo-Care Dual Lumen Umbilical Catheter available in?

    The Neo-Care Dual Lumen Umbilical Catheter is provided in various sizes to accommodate different patient needs.

  • How is the Neo-Care Dual Lumen Umbilical Catheter regulated?

    The device is regulated under regulation number 880.5200 and has a product code of FOS, classified as a class 2 device.