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Namic Contrast & Fluid Delivery Spikes(Various)

by North American Instrument Corp.

510(k) K852140

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK852140 Date30 May 1985ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0764-2025 FDA Class I initiated 16 Dec 2024

    Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

    • Ongoing Z-1807-2024 FDA Class II initiated 12 Mar 2024

    Products have a lack of sterility assurance.

    • Terminated Z-1853-2017 FDA Class II initiated 13 Jan 2017

    The product has the potential to be non-sterile as it was not packaged in accordance to specification.

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  • Withdrawn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

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