Cleared Traditional

K872154 - MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH

K872154 is an FDA 510(k) clearance for MODIFIED INFO INSERTS FOR PRUITT IRRI.-..., manufactured by Ideas For Medicine, Inc.. The device is a Class 2 Cardiovascular device with product code DQT cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K872154 · Ideas For Medicine, Inc. · Cardiovascular device
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Aug 1987
Decision
63d
Days
Class 2
Risk

K872154 is an FDA 510(k) clearance for the MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH. Classified as Occluder, Catheter Tip (product code DQT), Class II - Special Controls.

Submitted by Ideas For Medicine, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 3, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1370 - 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: 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 Ideas For Medicine, Inc. devices

FDA 510(k) Submission Details - K872154

510(k) Number K872154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date August 03, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQT Device Classification - Class 2, Special Controls

Product Code DQT Occluder, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1370
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 - DQT Occluder, Catheter Tip

Devices cleared under the same product code (DQT) and FDA review panel - the closest regulatory comparables to K872154.
AVD INTIMAX OCCLUSION CATHETER
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PERFUSION CATHETER
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