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Clave Neutron

by ICU Medical, Inc.

510(k) K100434

Clave Neutron is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K100434 on 9 Jul 2010, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100434 Date9 Jul 2010ClearedStatusActive

Official records

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1719-2022 FDA Class II initiated 1 Aug 2022

    Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

  • 2 recalls, same reason

    • Terminated Z-0261-2021 FDA Class II initiated 6 Jul 2020
    • Terminated Z-0182-2021 FDA Class II initiated 6 Jul 2020

    Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Timeline

4 dated events

  1. Cleared FDA 510(k) K100434
  2. Recall initiated FDA recalls Z-0261-2021
  3. Recall initiated FDA recalls Z-0182-2021
  4. Recall initiated FDA recalls Z-1719-2022

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code FPA (Set, Administration, Intravascular).

Other devices from ICU Medical, Inc.

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