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Eva Empty Solution Container

by Metrix Co.

510(k) K030888

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

16 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 · Special NumberK030888 Date2 Apr 2003ClearedStatusActive

Recalls

17 recalls · 16 ongoing · FDA

  • 16 recalls, same reason

    • Ongoing Z-0335-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0334-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0339-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0332-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0342-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0337-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0330-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0343-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0341-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0344-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0340-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0338-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0345-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0336-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0331-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0333-2025 FDA Class II initiated 9 Oct 2024

    A limited number of IV bags have been found to leak during filling.

    • Terminated Z-2260-2016 FDA Class II initiated 23 Jun 2016 on shared 510(k) K030888

    An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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