Cleared Traditional

K933839 - MASTER SCREEN PNUEMO

K933839 is an FDA 510(k) clearance for MASTER SCREEN PNUEMO, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K933839 · Erich Jaeger, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
214d
Days
Class 2
Risk

K933839 is an FDA 510(k) clearance for the MASTER SCREEN PNUEMO. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 214 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Erich Jaeger, Inc. devices

FDA 510(k) Submission Details - K933839

510(k) Number K933839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1993
Decision Date March 07, 1994
Days to Decision 214 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
74d slower than avg
Panel avg: 140d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 16
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K933839.
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
K981366 · Sensor Medics Corp. · Oct 1998
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K942211 · Sensor Medics Corp. · Nov 1994
FLOWSCREEN
K932744 · Erich Jaeger, Inc. · Mar 1994
L.A.P. SPIROMETER
K864836 · Timeter Instrument Corp. · Mar 1987
SPIROMETRY MODULE
K861486 · Medical Graphics Corp. · May 1986
PFT SCREENER (SYSTEM 1100)
K812792 · Medical Graphics Corp. · Nov 1981