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Phd Personal Hemodialysis Instrument-1M101, Phd Water Pre-Treatment Kit-1W605, Phd Hard Plumbing Kit-1W604, Phd Blood Tub

by Aksys, Ltd.

510(k) K010131

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 · Traditional NumberK010131 Date26 Mar 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1239-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006

    The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.

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  • Withdrawn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