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Filter Set, PMF 2028

by Sorensen Research

510(k) K760639

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 NumberK760639 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  • Withdrawn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, 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.

This device is a filter set accessory for hemodialysis blood circuits, as defined in the device name and specifications. It is classified as a Class II medical device under regulation number 876.5820 and product code KOC.

The device received traditional 510(k) clearance (K760639) from the FDA on October 15, 1976, and is substantially equivalent to a predicate device. It was reviewed by the Gastroenterology and Urology advisory committee and is manufactured by Sorensen Research in McHenry, Illinois.

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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 FILTER SET PMF 2028 used for?

    The FILTER SET PMF 2028 is an accessory designed for use in hemodialysis blood circuits, as specified in its device name and intended to support the filtration function within extracorporeal blood flow systems during dialysis treatment.

  • How is the FILTER SET PMF 2028 supplied or packaged?

    The device data does not specify packaging details, sterilization state, or whether the FILTER SET PMF 2028 is single-use or reusable; therefore, no information on its supply format can be derived from the provided authorization records.

  • What regulatory pathway was used for the FILTER SET PMF 2028?

    The FILTER SET PMF 2028 received traditional 510(k) clearance (K760639) from the FDA on October 15, 1976, based on a determination of substantial equivalence to a predicate device, following review by the Gastroenterology and Urology advisory committee.