Cleared Traditional

ARTIFICIAL K-NOSE BREATHAID (K771431) - FDA 510(k) Clearance

K771431 · Terumo America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
58d
Days
-
Risk

K771431 is an FDA 510(k) clearance for the ARTIFICIAL K-NOSE BREATHAID.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977 after a review of 58 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 Terumo America, Inc. devices

Submission Details

510(k) Number K771431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date September 28, 1977
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -