Cleared Traditional

K800222 - MODEL 412 ELECTROFLUIDIC MANOMETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800222 · Med-Tek Corp. · Cardiovascular device
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Feb 1980
Decision
25d
Days
Class 2
Risk

K800222 is an FDA 510(k) clearance for the MODEL 412 ELECTROFLUIDIC MANOMETER. Classified as System, Phonocatheter, Intracavitary (product code DXW), Class II - Special Controls.

Submitted by Med-Tek Corp. (Mchenry, US). The FDA issued a Cleared decision on February 29, 1980 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1270 - 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 Med-Tek Corp. devices

Submission Details

510(k) Number K800222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1980
Decision Date February 29, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXW System, Phonocatheter, Intracavitary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1270
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.