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Neo-Care Lumber Puncture Kit

by Klein-Baker Medical, Inc.

510(k) K970997

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 NumberK970997 Date22 May 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  • Withdrawn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
MIA
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Lumbar Puncture Kit is a spinal needle device classified as a short-term spinal needle. It is designed to facilitate spinal fluid collection and assist in diagnostic procedures for neonates.

This device is supplied as a single-use, disposable procedural tray containing the medical components required to perform a lumbar puncture. It is intended for use by healthcare professionals in clinical settings. The device has received FDA 510(k) clearance.

Other devices from Klein-Baker Medical, Inc.

Questions

AI-generated answers, 25 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 intended use of the Neo-Care Lumbar Puncture Kit?

    This device is designed to facilitate spinal fluid collection and assist in diagnostic procedures specifically for neonates in clinical settings.

  • Is this kit intended for multiple uses?

    No, the Neo-Care Lumbar Puncture Kit is supplied as a single-use, disposable procedural tray. It is intended to be used once and then discarded to maintain procedural safety.

  • What components are included in the kit?

    The kit is a procedural tray containing the necessary medical components required to perform a lumbar puncture, including a short-term spinal needle.

  • Has this device received regulatory authorization?

    Yes, the Neo-Care Lumbar Puncture Kit has received FDA 510(k) clearance under the K970997 submission.