Cleared Traditional

K842843 - DRYDEN SCAVENGER INTERFACE SYSTEM

K842843 · Dryden Corp. · Cardiovascular device
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Jul 1984
Decision
7d
Days
-
Risk

K842843 is an FDA 510(k) clearance for the DRYDEN SCAVENGER INTERFACE SYSTEM.

Submitted by Dryden Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 7 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 Dryden Corp. devices

Submission Details

510(k) Number K842843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date July 27, 1984
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -