Cleared Traditional

K942779 - DISPOSABLE BACTERIOLOGICAL FILTER

K942779 is an FDA 510(k) clearance for DISPOSABLE BACTERIOLOGICAL FILTER, manufactured by Vitalograph, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K942779 · Vitalograph, Inc. · Anesthesiology device
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Jul 1994
Decision
30d
Days
Class 2
Risk

K942779 is an FDA 510(k) clearance for the DISPOSABLE BACTERIOLOGICAL FILTER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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.

FDA 510(k) Submission Details - K942779

510(k) Number K942779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date July 13, 1994
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZG Spirometer, Diagnostic

All 227
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K942779.
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
K943546 · Spirosoft Northamerica, Inc. · Feb 1995
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
ADAM SHELL THERMOCOUPLE ASSEMBLY
K944175 · Pro-Tech Services, Inc. · Oct 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936 · Allied Healthcare Products, Inc. · Feb 1994
GS-MODULAR (GOLD STANDARD - MODULAR)
K925459 · Warren E. Collins, Inc. · Feb 1994
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · Sensor Medics Corp. · Oct 1993
K942779 · DISPOSABLE BACTERIOLOGICAL FILTER
Download PDF Vitalograph, Inc.