Cleared Traditional

K873521 - BRONCHODILATOR TEE - 9056 SERIES

K873521 is an FDA 510(k) clearance for BRONCHODILATOR TEE - 9056 SERIES, manufactured by Boehringer Laboratories. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K873521

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
Combination Product No
PCCP Authorized No
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.

CAF Device Classification - Class 2, Special Controls

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 245
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K873521.
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
MICROCIRRUS MEDICAL NEBULIZER
K881935 · Dhd Medical Products Div. Diemolding Corp. · Jun 1988
INSPIRON NEBULO BASIC EXTERNAL HEATER
K880304 · Intertech Resources, Inc. · Mar 1988
ASTHMAKIT
K874047 · Dhd Medical Products Div. Diemolding Corp. · Feb 1988
RESPIRGARD II NEBULIZER SYSTEM
K874395 · Marquest Medical Products, Inc. · Dec 1987
HOYER SOLVET
K873395 · Infrasonics Corp. · Oct 1987