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Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber Dialyzer

by National Medical Care, Medical Products Div., Inc.

510(k) K952343

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 NumberK952343 Date22 Dec 1995ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Focua 90R, 90HR, 120R, 120HR, 160R, and 160HR are Dialyzer, Capillary, Hollow Fiber, designed for hemodialysis. These devices utilize semipermeable hollow fiber membranes to filter blood, removing waste products and excess fluids during renal replacement therapy. Each variant is engineered to accommodate specific patient needs, with differing membrane surface areas and filtration capacities. They are classified under FDA regulation 876.5820 as Class II medical devices.

These dialyzers are intended for single-use in clinical settings, such as hospitals and dialysis centers. Supplied sterile and packaged for one-time use, they require proper handling and storage as per manufacturer guidelines to maintain sterility. The devices are compatible with standard hemodialysis machines and are regulated under FDA 510(k) clearance (K952343), with a decision of Substantially Equivalent (SESE). No MRI safety information is specified, and sizes are differentiated by model number only.

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