Cleared Traditional

K780626 - VENTURI OXYGEN MASK

K780626 is an FDA 510(k) clearance for VENTURI OXYGEN MASK, manufactured by Hospitak, Inc.. The device is a Class 1 Anesthesiology device with product code BYF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K780626 · Hospitak, Inc. · Anesthesiology device
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May 1978
Decision
42d
Days
Class 1
Risk

K780626 is an FDA 510(k) clearance for the VENTURI OXYGEN MASK. Classified as Mask, Oxygen, Low Concentration, Venturi (product code BYF), Class I - General Controls.

Submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 42 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

FDA 510(k) Submission Details - K780626

510(k) Number K780626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1978
Decision Date May 26, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

BYF Device Classification - Class 1, General Controls

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.

Regulatory Peers - BYF Mask, Oxygen, Low Concentration, Venturi

All 11
Devices cleared under the same product code (BYF) and FDA review panel - the closest regulatory comparables to K780626.
ADULT & PEDIATRIC TRACHEOSTOMY MASKS
K810946 · Airlife, Inc. · Jun 1981
AIR ENTRAINMENT TRACH T
K810947 · Airlife, Inc. · Jun 1981
MASK, PERCENTO
K790146 · Airlife, Inc. · Feb 1979
CONCHAPAK OXYGEN DILUTER
K780011 · Respiratory Care, Inc. · Feb 1978
OXYGEN MASK, AIR-ENTRAINMENT
K772127 · Salter Labs · Jan 1978
2 JET SET
K771385 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1977