Cleared Traditional

K913943 - SERIM DISINTEK REAGENT STRIPS

K913943 is an FDA 510(k) clearance for SERIM DISINTEK REAGENT STRIPS, manufactured by Serim Research Corp.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K913943 · Serim Research Corp. · General Hospital
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Mar 1992
Decision
204d
Days
Class 2
Risk

K913943 is an FDA 510(k) clearance for the SERIM DISINTEK REAGENT STRIPS. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 204 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K913943

510(k) Number K913943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1991
Decision Date March 26, 1992
Days to Decision 204 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 129d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 General Hospital devices follow this clearance model.

Regulatory Peers - MED Sterilant, Medical Devices

All 63
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K913943.
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K875280 · Steris C/O Medical Device Consultants, Inc. · Sep 1988
K913943 · SERIM DISINTEK REAGENT STRIPS
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