Cleared Traditional

K912144 - SIMON NITINOL FILTER, MODIFICATION

K912144 is an FDA 510(k) clearance for SIMON NITINOL FILTER, manufactured by Nitinol Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K912144 · Nitinol Medical Technologies, Inc. · Cardiovascular device
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Oct 1991
Decision
157d
Days
Class 2
Risk

K912144 is an FDA 510(k) clearance for the SIMON NITINOL FILTER, MODIFICATION. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Nitinol Medical Technologies, Inc. (New York, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K912144

510(k) Number K912144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date October 17, 1991
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTK Device Classification - Class 2, Special Controls

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTK Filter, Intravascular, Cardiovascular

All 82
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K912144.
SIMON NITINOL FILTER
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K901659 · Boston Scientific Corp · Nov 1990
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
K901235 · Boston Scientific Corp · Oct 1990
K912144 · SIMON NITINOL FILTER, MODIFICATION
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