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Coil Dialysis Models DM-360 and DM-360-

by Estracorporeal, Inc.

510(k) K790382

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 NumberK790382 Date2 May 1979ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 25 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 Coil Dialysis, models DM-360 and DM-360-, is a coil canister component used in dialysis systems. It is designed to house the coil-type dialyzer through which blood passes during hemodialysis treatment.

This device is classified as FDA Class 2 and received FDA 510(k) clearance under K790382. It is manufactured by Estracorporeal, Inc. and is regulated under 21 CFR 876.5820.

Other devices from Estracorporeal, Inc.