Cleared Traditional

K932014 - AMBU DISPOSABLE FACE MASK

K932014 is an FDA 510(k) clearance for AMBU DISPOSABLE FACE MASK, manufactured by Ambu, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K932014 · Ambu, Inc. · Anesthesiology device
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Jun 1993
Decision
60d
Days
Class 1
Risk

K932014 is an FDA 510(k) clearance for the AMBU DISPOSABLE FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 60 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 Ambu, Inc. devices

FDA 510(k) Submission Details - K932014

510(k) Number K932014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date June 22, 1993
Days to Decision 60 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 140d · This submission: 60d
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 29
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K932014.
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
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · Ventlab Corp. · Sep 1990
ANESTHESIA/RESPIRATORY DISPOSABLE MASK
K891316 · Concord/Portex · Aug 1989
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989