Skip to content

Filter Set PMF 2448

by Sorensen Research

510(k) K760628

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 NumberK760628 Date15 Oct 1976ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 24 Sep 2026

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

This device is an accessory for blood circuit hemodialysis, as defined by its classification name and device type. It is a filter set designed for use in hemodialysis procedures.

It is supplied as a non-sterile, reusable device intended for use in clinical settings such as gastroenterology and urology. The device has received FDA 510(k) clearance under K760628, is classified as Class II, and is regulated under regulation number 876.5820 with product code KOC.

Other devices from Sorensen Research

See all devices from Sorensen Research →