Cleared Traditional

K952215 - SERIM HISENSE TEST KIT

K952215 is an FDA 510(k) clearance for SERIM HISENSE TEST KIT, manufactured by Serim Research Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K952215 · Serim Research Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
90d
Days
Class 2
Risk

K952215 is an FDA 510(k) clearance for the SERIM HISENSE TEST KIT. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on August 9, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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 Serim Research Corp. devices

FDA 510(k) Submission Details - K952215

510(k) Number K952215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1995
Decision Date August 09, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 - FIP Subsystem, Water Purification

All 52
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K952215.
PORTABLE REVERSE OSMOSIS MACHINE
K954928 · Better Water, Inc. · Jan 1996
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995
RENAGUARD DIALYSATE FILTER
K945136 · Minntech Corp. · Feb 1995
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984
HEMO-RO WATER PURIFICATION SYS
K841403 · Millipore Corp. · Jul 1984