Cleared Traditional

K945440 - DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK

K945440 is an FDA 510(k) clearance for DISPOSABLE, manufactured by Fvtnks. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 1-day FDA review.

K945440 · Fvtnks · Anesthesiology device
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Nov 1994
Decision
1d
Days
Class 1
Risk

K945440 is an FDA 510(k) clearance for the DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Fvtnks (Indianapolis, US). The FDA issued a Cleared decision on November 8, 1994 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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 Fvtnks devices

FDA 510(k) Submission Details - K945440

510(k) Number K945440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date November 08, 1994
Days to Decision 1 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 140d · This submission: 1d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
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 - BSJ Mask, Gas, Anesthetic

All 30
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K945440.
SuperNO2VA Device
K163277 · Revolutionary Medical Devices, Inc. · Oct 2017
ANESTHESIA FACE MASK
K953295 · Mallinckrodt Medical · Aug 1995
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · Promedic, Inc. · Jun 1995
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · Ventlab Corp. · Sep 1990
ANESTHESIA/RESPIRATORY DISPOSABLE MASK
K891316 · Concord/Portex · Aug 1989