Cleared Traditional

K964264 - HIGH RANGE PEROXIDE TEST STRIP

K964264 is an FDA 510(k) clearance for HIGH RANGE PEROXIDE TEST STRIP, manufactured by Integrated Biomedical Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K964264 · Integrated Biomedical Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
234d
Days
Class 2
Risk

K964264 is an FDA 510(k) clearance for the HIGH RANGE PEROXIDE TEST STRIP. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Integrated Biomedical Technology, Inc. (Elkhart, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 234 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integrated Biomedical Technology, Inc. devices

FDA 510(k) Submission Details - K964264

510(k) Number K964264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date June 16, 1997
Days to Decision 234 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 130d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKP Device Classification - Class 2, Special Controls

Product Code FKP System, Dialysate Delivery, Single Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKP System, Dialysate Delivery, Single Patient

All 37
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K964264.
NXSTAGE DOSING CALCULATOR
K130460 · Nxstage Medical, Inc. · Jul 2013
ONEVIEW INTERFACE
K040074 · Nxstage Medical, Inc. · Apr 2004
FRESENIUS ICARE MONITORING SYSTEM
K021060 · Fresenius Medical Care North America · Nov 2002
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423 · Fresenius USA, Inc. · Jun 1996
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
K930181 · Fresenius USA, Inc. · Nov 1995
SPS 1550 SINGLE NEEDLE PATIENT SYSTEM
K922757 · Baxter Healthcare Corp · Feb 1995