Cleared Traditional

K955483 - TRACH MASK MODEL (245, 246) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K955483 · Hospitak, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
89d
Days
Class 1
Risk

K955483 is an FDA 510(k) clearance for the TRACH MASK MODEL (245, 246). Classified as Mask, Oxygen, Low Concentration, Venturi (product code BYF), Class I - General Controls.

Submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on February 28, 1996 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5600 - the FDA anesthesiology and respiratory device framework. 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 Hospitak, Inc. devices

Submission Details

510(k) Number K955483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date February 28, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 139d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYF Mask, Oxygen, Low Concentration, Venturi
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.