510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K982813Substantially Equivalent

Naturalyte, Model # 08-4004-1

Kaybath, Inc., Waipahu HI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982813 is the FDA 510(k) clearance record for NATURALYTE, MODEL # 08-4004-1, a class II device, cleared for Kaybath, Inc. on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list one 510(k) clearance for Kaybath, Inc. As of , FDA records show no recalls naming K982813.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kaybath, Inc. 95-547 Ukee St., #110, Waipahu HI
510(k) summary
Summary
Third party review
No

Clearances, product code KPO

Trailing 12 months
2 clearances under product code KPO in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260