Cleared Traditional

K803185 - NON-CONDUCTIVE ANESTHESIA FACE MASK

K803185 is the FDA 510(k) clearance for NON-CONDUCTIVE ANESTHESIA FACE MASK by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Anesthesiology device (product code BSJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K803185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Anesthesiology device
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Jan 1981
Decision
20d
Days
Class 1
Risk

K803185 is an FDA 510(k) clearance for the NON-CONDUCTIVE ANESTHESIA FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 5, 1981 after a review of 20 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K803185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1980
Decision Date January 05, 1981
Days to Decision 20 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
120d faster than avg
Panel avg: 140d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 20
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K803185.
MASKS
K830982 · Medovations, Inc. · May 1983
NON CONDUCTIVE PEDIATRIC ANES. FACE
K821045 · Vital Signs, Inc. · Apr 1982
OHIO NONCONDUCTIVE RBS TYPE FACE MASK
K810990 · Ohio Medical Products · Apr 1981
NON-CONDUCTIVE, SINGLE USE FACE MASK #55
K801251 · Vital Signs, Inc. · Jun 1980
ACCUTRON POLLUTION REDUCER
K790638 · Parker Laboratories, Inc. · May 1979