Filter Set PMF 2288

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

510(k) Number

K760626 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Introducer, Cat. #int-05FR.

  Class II

  FDA 510(k) K771042 Active Cleared 13 Jul 1977

• Transducer Dome DS106

  Class II

  FDA 510(k) K833096 Active Cleared 3 Nov 1983

• Intk-08 8 French Introducer Kit W/Side

  Class II

  FDA 510(k) K812325 Active Cleared 21 Sep 1981

• DNC 162 Vinca-Flo

  Class II

  FDA 510(k) K770048 Active Cleared 14 Jan 1977

• Introducer, Cat. #int-06FR.

  Class II

  FDA 510(k) K771041 Active Cleared 13 Jul 1977

• Tall Floor Stand Tfs-01

  Class II

  FDA 510(k) K831939 Active Cleared 19 Jul 1983

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• What is the primary purpose of the Filter Set PMF 2288 in a hemodialysis treatment?

  The Filter Set PMF 2288 is designed as a blood circuit accessory for hemodialysis to remove impurities and manage fluid exchange during treatment. It ensures patient safety and treatment efficacy by filtering the blood as part of the dialysis system.

• Is the Filter Set PMF 2288 intended for reuse or is it a single-use device?

  The Filter Set PMF 2288 is explicitly supplied as a single-use item, meaning it is intended for one-time use in clinical settings like dialysis centers. This design helps maintain sterility and functionality for patient safety.

• What storage or handling guidelines should be followed to maintain the device’s sterility and functionality?

  The Filter Set PMF 2288 must be handled and stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use, proper storage conditions are critical to prevent contamination before use.

• How was the regulatory pathway for this device determined, and what does that mean for its use?

  The Filter Set PMF 2288 received FDA 510(k) clearance (K760626) under a traditional review process, determined to be substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device, ensuring it can be legally marketed and used in clinical hemodialysis settings.