Cleared Traditional

K932744 - FLOWSCREEN

K932744 is an FDA 510(k) clearance for FLOWSCREEN, 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 272-day FDA review.

K932744 · Erich Jaeger, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
272d
Days
Class 2
Risk

K932744 is an FDA 510(k) clearance for the FLOWSCREEN. 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 272 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 - K932744

510(k) Number K932744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date March 07, 1994
Days to Decision 272 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
132d slower than avg
Panel avg: 140d · This submission: 272d
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 K932744.
SpiroSphere
K173937 · Eresearchtechnology GmbH · Feb 2019
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
MASTER SCREEN PNUEMO
K933839 · Erich Jaeger, Inc. · Mar 1994
L.A.P. SPIROMETER
K864836 · Timeter Instrument Corp. · Mar 1987
SPIROMETRY MODULE
K861486 · Medical Graphics Corp. · May 1986