HemoCare Bicarbonate Concentrate Set (BCS)

by Deka Research and Development 510(k)

Active United States

510(k) K240920

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK240920	Date12 Jul 2024Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number: K240920
FDA Product Code: KPO

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

Other devices from Deka Research and Development

twiist Automated Insulin Delivery (AID) System

Class II
iiSure Infusion Set

Class II
Remunity System

Class II
Unity Subcutaneous Delivery System for Remodulin

Class II
Sparta Infusion Set for Insulin

Class II
DEKA Infusion System, DEKA Administration Set

Class II

See all devices from Deka Research and Development →