Cleared Traditional

K853409 - SCREENMATE

K853409 is an FDA 510(k) clearance for SCREENMATE, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K853409 · Erich Jaeger, Inc. · Anesthesiology device
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Feb 1986
Decision
177d
Days
Class 2
Risk

K853409 is an FDA 510(k) clearance for the SCREENMATE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on February 5, 1986 after a review of 177 days - an extended review 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: 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 - K853409

510(k) Number K853409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date February 05, 1986
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
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 50
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K853409.
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
SALTER VOLUCHEK 6600
K863656 · Salter Labs · Oct 1986
MODEL 2120 SPIROSCREEN
K854403 · Gould, Inc. · Jan 1986
PALL PULMONARY FUNCTION FILTER
K854062 · Pall Biomedical Products Co. · Nov 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985