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K100 Neutral Displacement Needle Free Connector

by Np Medical, Inc.

510(k) K130023

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 NumberK130023 Date3 Apr 2013ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
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 K100 Neutral Displacement Needle Free Connector is a medical device designed for needleless access to the IV line and/or IV catheter during IV therapy, allowing for direct injection, intermittent infusion, continuous infusion, or aspiration. It is a single patient use device.

The K100 Neutral Displacement Needle Free Connector is supplied for single patient use and is intended for use in a general hospital setting. It has been cleared under FDA 510K, with the reference number K130023.

Other devices from Np Medical

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 K100 Neutral Displacement Needle Free Connector used for?

    The K100 Neutral Displacement Needle Free Connector is used for needleless access to the IV line and/or IV catheter during IV therapy, allowing for direct injection, intermittent infusion, continuous infusion, or aspiration.

  • Is the K100 Neutral Displacement Needle Free Connector for single patient use?

    Yes, the K100 Neutral Displacement Needle Free Connector is supplied for single patient use, intended for use in a general hospital setting.

  • What is the regulatory status of the K100 Neutral Displacement Needle Free Connector?

    The K100 Neutral Displacement Needle Free Connector has been cleared under FDA 510K, with the reference number K130023, indicating it is substantially equivalent to a predicate device.