Cleared Traditional

K914123 - SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS

K914123 is an FDA 510(k) clearance for SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS, manufactured by Serim Research Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K914123 · Serim Research Corp. · Gastroenterology & Urology device
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Apr 1992
Decision
209d
Days
Class 2
Risk

K914123 is an FDA 510(k) clearance for the SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on April 9, 1992 after a review of 209 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 Serim Research Corp. devices

FDA 510(k) Submission Details - K914123

510(k) Number K914123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date April 09, 1992
Days to Decision 209 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
78d slower than avg
Panel avg: 131d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
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 - LIF Dialyzer Reprocessing System

All 30
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K914123.
RENALIN REUSE CART
K941867 · Renal Scientific Service, Inc. · Jan 1996
DRS 4 ND DIALYZER REPROCESSING SYSTEM
K944539 · Seratronics, Inc. · Nov 1995
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
K923529 · Seratronics, Inc. · Aug 1994
DRS-4 DIALYZER REPROCESSING SYSTEM
K914580 · Seratronics, Inc. · Feb 1992
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · Serim Research Corp. · Jun 1991
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · Serim Research Corp. · Jun 1991