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Zetajet

by Bioject, Inc.

510(k) K090003

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK090003 Date2 Apr 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1541-2012 FDA Unclassified (pre-2012) initiated 1 Jun 2010

    Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.

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  • Withdrawn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
KZE
Device Class
Class II
Regulation
21 CFR Part 880.5430
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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