510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953854Substantially Equivalent

Watercheck Reagent Strip for Chlorine & Peroxide

Integrated Biomedical Technology, Inc., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953854 is the FDA 510(k) clearance record for WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE, a class II device, cleared for Integrated Biomedical Technology, Inc. on under FDA product code FKP (System, Dialysate Delivery, Single Patient). FDA records list 3 510(k) clearances for Integrated Biomedical Technology, Inc., from to . As of , FDA records show no recalls naming K953854.

Clearance record

Decision date
Received
(217 days to decision)
Product code
FKP System, Dialysate Delivery, Single Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Integrated Biomedical Technology, Inc. 51819 Winding Waters Ln., Elkhart IN
510(k) summary
Summary
Third party review
No

Clearances, product code FKP

Trailing 12 months

FDA records hold no clearances under product code FKP in the trailing twelve months.

FDA records show no clearances under product code FKP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260