Packets for the Prep of Dialysates &

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K842154 ↗

FDA Product Code

FKQ

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Fibrinostika Tdp Microelisa System

  Class II

  FDA 510(k) K915698 Active Cleared 5 Aug 1992

• Nephross I.Q. Andante

  Class II

  FDA 510(k) K874549 Active Cleared 29 Jan 1988

• Mda Protein Assay

  Class II

  FDA 510(k) K925617 Active Cleared 27 Jan 1994

• Bsm 2000 Dialysis Machine

  Class II

  FDA 510(k) K840062 Active Cleared 22 Mar 1984

• Bact/Alert Culture Bottles

  Class I

  FDA 510(k) K973305 Active Cleared 17 Nov 1997

• Nuclisens Cmv PP67

  Class II

  FDA 510(k) K983762 Active Cleared 15 Sep 1999

See all devices from Organon Teknika Corp. →

• What clinical setting is this device intended for, and how does it differ from single-patient dialysate preparation methods?

  This device is designed specifically for centralized hemodialysis facilities where multiple patients are treated simultaneously. Unlike single-patient dialysate systems, these packets allow automated or manual preparation of sterile dialysate solutions in bulk, ensuring consistency across treatments. The premeasured components dissolve to create dialysate on-demand, streamlining workflows in high-volume dialysis centers.

• Are these packets reusable, or do they require single-use disposal after one patient’s treatment?

  The packets are explicitly labeled as single-use items, meaning each packet must be discarded after dissolving to prepare dialysate—even if unused components remain. This design ensures sterility and prevents cross-contamination in multi-patient settings, aligning with regulated dialysis facility protocols.

• What storage conditions must be followed to keep the packets effective until use?

  The packets must be stored according to the manufacturer’s instructions to preserve their integrity. While exact conditions aren’t detailed here, typical requirements for sterile, single-use medical packets include protection from moisture, extreme temperatures, and physical damage. Always refer to the packaging or accompanying documentation for precise storage guidelines.

• How do I identify the correct packet type for my facility’s dialysate needs?

  These packets are available under multiple reference codes (e.g., *FKQ*), which likely correspond to specific dialysate formulations or patient requirements. Verify the correct code with your facility’s nephrology team or the manufacturer, as mismatched packets could affect treatment efficacy. The product code *FKQ* is one example, but others may exist for specialized applications.

• What regulatory pathway was followed for this device’s clearance, and how does that affect its use?

  The device was cleared via an FDA 510(k) submission (K842154) under the classification *System, Dialysate Delivery, Central Multiple Patient* (regulatory number 876.5820), with a *Substantially Equivalent* determination. This means it was deemed comparable to a previously approved predicate device, ensuring compliance with U.S. medical device regulations. Facilities using it must adhere to FDA and facility-specific protocols for sterile preparation and patient safety.