Cleared Traditional

K945894 - MASK

K945894 is an FDA 510(k) clearance for MASK, manufactured by Hans Rudolph, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K945894 · Hans Rudolph, Inc. · Anesthesiology device
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Jan 1995
Decision
56d
Days
Class 1
Risk

K945894 is an FDA 510(k) clearance for the MASK, GAS, ANESTHETIC. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 56 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 Hans Rudolph, Inc. devices

FDA 510(k) Submission Details - K945894

510(k) Number K945894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date January 27, 1995
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
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 27
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K945894.
ANESTHESIA FACE MASK
K953295 · Mallinckrodt Medical · Aug 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
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989
MODIFIED CUSHION-FLEX(TM)
K890108 · Life Design Systems, Inc. · Jan 1989