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Prisma Cfm (Continuous Fluid Management System)

by Gambro Renal Care Products

510(k) K993064

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK993064 Date6 Oct 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1545-05 FDA Unclassified (pre-2012) initiated 16 Aug 2005

    Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.

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  • Withdrawn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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