Cleared Traditional

K840535 - DISPOS. ANESTHESIA FACE MASK

K840535 is an FDA 510(k) clearance for DISPOS. ANESTHESIA FACE MASK, manufactured by Marquest Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K840535 · Marquest Medical Products, Inc. · Anesthesiology device
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Feb 1984
Decision
13d
Days
Class 1
Risk

K840535 is an FDA 510(k) clearance for the DISPOS. ANESTHESIA FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Marquest Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 13 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 Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K840535

510(k) Number K840535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date February 21, 1984
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
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 20
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K840535.
MEDIPART FACE MASK & FILTER MP-30XM
K844493 · Medipart Jerry Alexander · Dec 1984
MEDIPART FACE MASK MP-XM
K844494 · Medipart Jerry Alexander · Dec 1984
CUSHION-FLEX TM
K843169 · Life Design Systems, Inc. · Aug 1984
PREMIUM DABM DISPOS. ANES. BREATH MASK
K840452 · Ohio Medical Products · Feb 1984
NON CONDUCTIVE ANESTHESIA FACEMASK
K831713 · Vital Signs, Inc. · Jul 1983
MASKS
K830982 · Medovations, Inc. · May 1983