Cleared Traditional

NASSAL PRESSURE/FLOW RECORDER (K772193) - FDA 510(k) Clearance

K772193 · Adco Labs. · Ear, Nose, Throat device
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Dec 1977
Decision
4d
Days
-
Risk

K772193 is an FDA 510(k) clearance for the NASSAL PRESSURE/FLOW RECORDER.

Submitted by Adco Labs. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1977 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat 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 Adco Labs. devices

Submission Details

510(k) Number K772193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1977
Decision Date December 02, 1977
Days to Decision 4 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 89d · This submission: 4d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETL
Device Class -