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Beta-Cap D Adapter

by Quinton, Inc. 510(k)

Active United States

510(k) K830208

Overview

The Beta-Cap D Adapter is a component of a peritoneal dialysis system, designed to connect and facilitate the delivery of peritoneal dialysis solutions. It serves as an intermediary connector between the dialysis fluid source and the patient’s peritoneal cavity, ensuring proper fluid flow during automated peritoneal dialysis procedures.

This adapter is supplied as a single-use device and is intended for use in peritoneal dialysis settings. It is classified under FDA regulation number 876.5630 and has received FDA 510(k) clearance (K830208) as substantially equivalent to a predicate device. The adapter is packaged in sterile form and must be discarded after a single use to maintain sterility and patient safety.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830208 Date7 Mar 1983ClearedStatusActive

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
FKX
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Beta-Cap D Adapter used for?

    The Beta-Cap D Adapter is a component of a peritoneal dialysis system designed to connect the dialysis fluid source to the patient’s peritoneal cavity. It facilitates the delivery of peritoneal dialysis solutions during automated procedures, ensuring proper fluid flow while maintaining a sterile connection.

  • Is the Beta-Cap D Adapter single-use or reusable?

    The Beta-Cap D Adapter is supplied as a single-use device. It is packaged in sterile form and must be discarded after one use to maintain sterility and patient safety, as per manufacturer guidelines.

  • What regulatory approval does the Beta-Cap D Adapter have?

    The Beta-Cap D Adapter has received FDA 510(k) clearance (K830208) as substantially equivalent to a predicate device. It is classified under FDA regulation number 876.5630 and is intended for use in peritoneal dialysis settings.

  • How is the Beta-Cap D Adapter supplied?

    The adapter is supplied in a sterile package, ensuring it is ready for immediate use in peritoneal dialysis procedures. The sterile packaging guarantees contamination control before first use.

  • What types of peritoneal dialysis systems can use the Beta-Cap D Adapter?

    The Beta-Cap D Adapter is specifically designed for automated peritoneal dialysis systems. It connects the dialysis fluid source to the patient’s peritoneal cavity, ensuring compatibility with systems that rely on automated fluid exchange for treatment.