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Clave Vial Access Spike

by ICU Medical, Inc.

510(k) K934591

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 NumberK934591 Date16 Feb 1994ClearedStatusActive

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  • Withdrawn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
FMI
Device class
Class II
Regulation
21 CFR Part 880.5570
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Clave Vial Access Spike is a vial access spike designed for connecting to multi-dose vials to facilitate medication administration. It provides a sterile, needle-free connection point for needleless syringes or IV lines, enabling safe and efficient transfer of fluids and medications without direct needle exposure.

This device is intended for single-use in clinical settings, including hospitals and pharmacies, and is supplied sterile. It is classified under FDA product code FMI and was cleared via a Traditional 510(k) pathway in 1994. The spike is compatible with standard multi-dose vial systems and adheres to regulatory standards for intravenous administration accessories.

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