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Tablo Cartridge

by Home Dialysis Plus

510(k) K140841

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK140841 Date11 Sep 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FJK
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TABLO CARTRIDGE is a component of the Tablo Hemodialysis System, designed for home-based dialysis treatments. It is classified as a Set, Tubing, Blood, with or without an anti-regurgitation valve, and is intended for use in intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/SLEDD), and prolonged intermittent renal dialysis (PIRD).

The cartridge is supplied sterile and is intended for single-use. It is compatible with MRI safety standards and should be stored in a controlled environment. The device is regulated under FDA 510(k) clearance (K140841) and is classified as a Class II device with special controls.

Other devices from Home Dialysis Plus

  • Tablo Console

    Class II

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TABLO CARTRIDGE used for?

    It is a sterile, single-use blood set component for the Tablo Hemodialysis System. It is intended for intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/SLEDD), and prolonged intermittent renal dialysis (PIRD).

  • Is the TABLO CARTRIDGE intended for single use?

    Yes, the device is supplied sterile and is intended for single-use only. It should be discarded after one treatment to maintain safety and efficacy.

  • Does the TABLO CARTRIDGE have any safety features?

    The cartridge is classified as a Set, Tubing, Blood, with or without an anti-regurgitation valve. It is also compatible with MRI safety standards.

  • How should the TABLO CARTRIDGE be stored?

    The device should be stored in a controlled environment to maintain its sterility and integrity prior to use.