Cleared Traditional

JET VENTILATION ADAPTOR (K842456) - FDA 510(k) Clearance

K842456 · Portex, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
14d
Days
-
Risk

K842456 is an FDA 510(k) clearance for the JET VENTILATION ADAPTOR.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 14 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 Portex, Inc. devices

Submission Details

510(k) Number K842456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date July 06, 1984
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -