Cleared Traditional

K873521 - BRONCHODILATOR TEE - 9056 SERIES

K873521 is the FDA 510(k) clearance for BRONCHODILATOR TEE - 9056 SERIES by Boehringer Laboratories. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K873521 · Boehringer Laboratories · Anesthesiology device
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Mar 1988
Decision
183d
Days
Class 2
Risk

K873521 is an FDA 510(k) clearance for the BRONCHODILATOR TEE - 9056 SERIES. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 183 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Boehringer Laboratories devices

Submission Details

510(k) Number K873521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date March 02, 1988
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 140d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 94
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K873521.
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983