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KF-101-13 Dialyzer

by Extracorporeal Medical Specialities, Inc.

510(k) K822339

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 NumberK822339 Date16 Feb 1983ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The KF-101-13 Dialyzer is an accessory for blood circuit hemodialysis, classified under product code KOC as a Class II medical device with special controls. It is a substantially equivalent device cleared through the FDA 510(k) process.

It was manufactured by Extracorporeal Medical Specialities, Inc. in McHenry, Illinois, United States. The device received FDA clearance on February 16, 1983, under K822339, following a traditional review process.

Other devices from Extracorporeal Medical Specialities, Inc.

See all devices from Extracorporeal Medical Specialities, Inc. →

Questions

AI-generated answers, 6 Oct 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 KF-101-13 Dialyzer used for?

    The KF-101-13 Dialyzer is an accessory for blood circuit hemodialysis, designed to support extracorporeal blood treatment during dialysis procedures as part of the hemodialysis circuit setup.

  • Who manufactures the KF-101-13 Dialyzer and where is it made?

    The KF-101-13 Dialyzer is manufactured by Extracorporeal Medical Specialities, Inc. in McHenry, Illinois, United States, as specified in the device’s authorization and registration records.

  • How was the KF-101-13 Dialyzer cleared for market?

    The KF-101-13 Dialyzer received FDA clearance through the traditional 510(k) process on February 16, 1983, under submission K822339, demonstrating substantial equivalence to a legally marketed predicate device.

  • What regulatory classification and product code apply to the KF-101-13 Dialyzer?

    The KF-101-13 Dialyzer is classified as a Class II medical device under product code KOC, which corresponds to accessories for blood circuit hemodialysis, and is subject to special controls as required by its classification.