Skip to content

Maks Central Delivery SYS-11-200 Etc

by Erika, Inc. 510(k)

Active United States

510(k) K840859

Overview

The Maks Central Delivery Sys-11-200 Etc is a medical device classified as Accessories, Blood Circuit, Hemodialysis. It is substantially equivalent to other devices and is used in the medical specialties of Gastroenterology and Urology.

The device is supplied by Erika, Inc. and has been granted FDA 510K clearance with the number K840859. It is regulated under regulation number 876.5820 and has a product code of KOC. The device was cleared on May 22, 1984, after an 88-day review.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840859 Date22 May 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Erika, Inc.

See all devices from Erika, Inc. →

Questions

  • What medical specialties is the Maks Central Delivery Sys-11-200 Etc designed for?

    The Maks Central Delivery Sys-11-200 Etc is specifically designed for use in the medical specialties of Gastroenterology and Urology. This classification reflects its role as a blood circuit accessory in hemodialysis procedures, where it facilitates controlled delivery of fluids or medications in these specialized fields.

  • How is the Maks Central Delivery Sys-11-200 Etc supplied and what is its regulatory status?

    The Maks Central Delivery Sys-11-200 Etc is supplied by Erika, Inc. It holds an FDA 510(k) clearance with the number K840859, indicating it is classified as substantially equivalent to other predicate devices. The clearance was granted under regulation number 876.5820 and product code KOC, with a review process completed in 1984.

  • Is the Maks Central Delivery Sys-11-200 Etc intended for single-use or reuse?

    The device data does not explicitly state whether the Maks Central Delivery Sys-11-200 Etc is intended for single-use or reuse. However, as a blood circuit accessory used in hemodialysis, it is typically designed for single-use to ensure patient safety and sterility. Always refer to the manufacturer’s instructions for use for specific guidance.

  • What are the key specifications or features of the Maks Central Delivery Sys-11-200 Etc?

    The Maks Central Delivery Sys-11-200 Etc is categorized under Accessories, Blood Circuit, Hemodialysis. It is regulated under FDA product code KOC and falls under device class 2. The device was cleared through a traditional 510(k) review process, with a decision date of May 22, 1984. Additional technical specifications would require direct consultation of the manufacturer’s documentation.

  • Where can I find more information about the regulatory history of this device?

    The Maks Central Delivery Sys-11-200 Etc was reviewed by the FDA’s Gastroenterology-Urology (GU) Advisory Committee and received clearance on May 22, 1984, after an 88-day review. The device was submitted by Erika, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534. For detailed regulatory documentation, you may refer to the FDA’s openFDA database using the clearance number K840859.