Cleared Traditional

K843700 - ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- (FDA 510(k) Clearance)

K843700 · Future Impex Corp. · Cardiovascular device
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Oct 1984
Decision
34d
Days
-
Risk

K843700 is an FDA 510(k) clearance for the ST-200A W/MAXIMAL VOLUNTARY VENTILLAT-.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 34 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 Future Impex Corp. devices

Submission Details

510(k) Number K843700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1984
Decision Date October 24, 1984
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -