Cleared Traditional

K911628 - SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)

K911628 is an FDA 510(k) clearance for SERIM FORMALDEHYDE REAGENT STRIPS (1.O%..., 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 77-day FDA review.

K911628 · Serim Research Corp. · Gastroenterology & Urology device
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Jun 1991
Decision
77d
Days
Class 2
Risk

K911628 is an FDA 510(k) clearance for the SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%). 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 June 27, 1991 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Serim Research Corp. devices

FDA 510(k) Submission Details - K911628

510(k) Number K911628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date June 27, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 131d · This submission: 77d
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 K911628.
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
K923529 · Seratronics, Inc. · Aug 1994
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123 · Serim Research Corp. · Apr 1992
DRS-4 DIALYZER REPROCESSING SYSTEM
K914580 · Seratronics, Inc. · Feb 1992
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · Serim Research Corp. · Jun 1991
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · Serim Research Corp. · Apr 1991
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · Minntech Corp. · Nov 1990