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Blood Port Cap, Dialysate Port Cap, Red Hard Plastic

by Dayspring Medical, Inc.

510(k) K961040

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961040 Date11 Jun 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FJI
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.

This device is a Dialyzer, Capillary, Hollow Fiber, specifically a blood port cap and dialysate port cap made of red hard plastic. It is designed for use in dialysis systems to seal and protect ports during treatment.

It is supplied as a reusable component, cleared via FDA 510(k) K961040 under product code FJI, classified as Class II with special controls. The device was determined substantially equivalent and received clearance on June 11, 1996, following submission on March 14, 1996, by Dayspring Medical, Inc. in Boulder, Colorado.

Other devices from Dayspring Medical, 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 Blood Port Cap, Dialysate Port Cap, Red Hard Plastic used for?

    This device is designed to seal and protect blood and dialysate ports during dialysis treatment, ensuring system integrity and preventing contamination or fluid loss while in use as part of a dialysis system.

  • Is the Blood Port Cap, Dialysate Port Cap, Red Hard Plastic reusable or single-use?

    The device is supplied as a reusable component, meaning it can be cleaned and used multiple times according to the manufacturer's instructions and institutional reprocessing protocols for dialysis equipment.

  • What regulatory pathway was used for the Blood Port Cap, Dialysate Port Cap, Red Hard Plastic?

    The device received FDA 510(k) clearance under K961040, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as Class II with special controls under product code FJI.