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I.V. Additive Cap

by Baxa Corp., Sub. of Cook Group, Inc.

510(k) K802966

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 NumberK802966 Date7 Jan 1981ClearedStatusActive

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  • Withdrawn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
KPE
Device Class
Class II
Regulation
21 CFR Part 880.5025
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 I.V. Additive Cap is an intravenous container accessory designed for use in a general hospital setting. It functions as a closure or cap for intravenous containers.

This device is regulated under 21 CFR 880.5025 and received FDA 510(k) clearance in 1981. It is manufactured by Baxa Corp., a subsidiary of Cook Group, Inc.

Other devices from Baxa Corp., Sub. of Cook Group, Inc.

See all devices from Baxa Corp., Sub. of Cook Group, Inc. →

Questions

AI-generated answers, 27 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 primary purpose of the I.V. Additive Cap?

    The I.V. Additive Cap is designed to function as a closure or cap for intravenous containers within a general hospital setting.

  • Who is the manufacturer of this device?

    This device is manufactured by Baxa Corp., which is a subsidiary of the Cook Group, Inc.

  • What is the regulatory status of the I.V. Additive Cap?

    The device is regulated under 21 CFR 880.5025 and received FDA 510(k) clearance in 1981 under the K-number K802966.