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Naturalyte, Model # 08-4004-1

by Kaybath, Inc.

510(k) K982813

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 NumberK982813 Date6 Nov 1998ClearedStatusActive

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  • Withdrawn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
KPO
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 dialysate concentrate for hemodialysis, available in liquid or powder form. It is classified under product code KPO and regulation number 876.5820.

It is supplied by Kaybath, Inc. and was cleared via the FDA 510(k) process under submission K982813 on November 6, 1998. The device is intended for use in hemodialysis settings and is subject to special controls as a Class II medical device.

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 NATURALYTE, Model # 08-4004-1 used for?

    NATURALYTE, Model # 08-4004-1 is a dialysate concentrate for hemodialysis, intended for use in hemodialysis settings to prepare dialysate fluid that removes waste and excess fluid from blood during treatment.

  • How is NATURALYTE, Model # 08-4004-1 supplied and in what forms?

    NATURALYTE, Model # 08-4004-1 is supplied by Kaybath, Inc. in either liquid or powder form as a dialysate concentrate for hemodialysis, as specified in its FDA 510(k) clearance.

  • What regulatory pathway was used to clear NATURALYTE, Model # 08-4004-1?

    NATURALYTE, Model # 08-4004-1 was cleared via the FDA 510(k) process under submission K982813 on November 6, 1998, and is classified as a Class II medical device under product code KPO and regulation number 876.5820.