Cleared Traditional

SCREENMATE (K853409) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853409 · Erich Jaeger, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 29
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K853409.
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981