Cleared Traditional

K801756 - MMI/GAELTEC CATHETER TIP TRANSDUC

K801756 is the FDA 510(k) clearance for MMI/GAELTEC CATHETER TIP TRANSDUC by Medical Measurements, Inc.. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K801756 · Medical Measurements, Inc. · Cardiovascular device
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Aug 1980
Decision
23d
Days
Class 2
Risk

K801756 is an FDA 510(k) clearance for the MMI/GAELTEC CATHETER TIP TRANSDUC. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Medical Measurements, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Medical Measurements, Inc. devices

Submission Details

510(k) Number K801756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 20, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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.