Cleared Traditional

K843848 - AW TEST

K843848 is an FDA 510(k) clearance for AW TEST, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K843848 · Erich Jaeger, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
31d
Days
Class 2
Risk

K843848 is an FDA 510(k) clearance for the AW TEST. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1984 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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.

View all Erich Jaeger, Inc. devices

FDA 510(k) Submission Details - K843848

510(k) Number K843848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date November 01, 1984
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 24
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K843848.
Q-PLEX 1
K881235 · Quinton, Inc. · Mar 1989
ALVEO-DIFFUSION TEST
K853443 · Erich Jaeger, Inc. · Feb 1986
OXYSCREEN
K843860 · Erich Jaeger, Inc. · Dec 1984
APTA-BRONCHOSCREEN
K843852 · Erich Jaeger, Inc. · Nov 1984
PNEUMOSCREEN
K843849 · Erich Jaeger, Inc. · Oct 1984
PULMONARY FUNCTION LAB SYSTEM 1070
K822986 · Medical Graphics Corp. · Nov 1982