Cleared Traditional

K781219 - ECON-O2 (FDA 510(k) Clearance)

K781219 · Mountain Medical Equipment, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1978
Decision
45d
Days
-
Risk

K781219 is an FDA 510(k) clearance for the ECON-O2.

Submitted by Mountain Medical Equipment, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Mountain Medical Equipment, Inc. devices

Submission Details

510(k) Number K781219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1978
Decision Date August 31, 1978
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -