Skip to content

Capiox SX HardShell Reservoir

by Terumo Medical Corp.

510(k) K982223

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982223 Date10 Sep 1998ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Capiox Sx Hardshell Resevoir
510(k) Number
FDA product code
DTN
Device class
Class II
Regulation
21 CFR Part 870.4400
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Capiox SX HardShell Reservoir is a blood reservoir designed for use in cardiopulmonary bypass procedures. Classified as a Class II device under FDA regulation 870.4400, it serves as a component in maintaining and circulating blood during open-heart surgeries and related cardiovascular interventions.

This device is intended for single-use in controlled clinical settings, such as operating rooms, and is regulated under the FDA’s 510(k) clearance process. Supplied sterile and packaged for medical use, it adheres to cardiovascular device standards and is authorized under the traditional 510(k) pathway with a clearance date of September 10, 1998. No MRI safety or reusable specifications are noted in the regulatory data.

Other devices from Terumo Medical Corporation

See all devices from Terumo Medical Corporation →