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Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

by Baxter Healthcare Corporation

510(k) K212216

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212216 Date1 Apr 2022ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1224-2026 FDA Class II initiated 6 Jan 2026
    • Ongoing Z-1225-2026 FDA Class II initiated 6 Jan 2026

    There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

    • Ongoing Z-0084-2023 FDA Class II initiated 14 Sep 2022

    Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

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  • Withdrawn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
KDI
Device Class
Class II
Regulation
21 CFR Part 876.5860
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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