Cleared Traditional

K853443 - ALVEO-DIFFUSION TEST

K853443 is an FDA 510(k) clearance for ALVEO-DIFFUSION 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 189-day FDA review.

K853443 · Erich Jaeger, Inc. · Anesthesiology device
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Feb 1986
Decision
189d
Days
Class 2
Risk

K853443 is an FDA 510(k) clearance for the ALVEO-DIFFUSION TEST. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 189 days - an extended review 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: 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 - K853443

510(k) Number K853443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date February 21, 1986
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
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 K853443.
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
K915833 · Sensor Medics Corp. · Dec 1992
MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · Sensor Medics Corp. · Dec 1992
Q-PLEX 1
K881235 · Quinton, Inc. · Mar 1989
OXYSCREEN
K843860 · Erich Jaeger, Inc. · Dec 1984
AW TEST
K843848 · Erich Jaeger, Inc. · Nov 1984
APTA-BRONCHOSCREEN
K843852 · Erich Jaeger, Inc. · Nov 1984