Cleared Traditional

K821492 - BE#6006 VAR. RESIS. INSPIR. MUSCLE

K821492 is the FDA 510(k) clearance for BE#6006 VAR. RESIS. INSPIR. MUSCLE by Instrumentation Industries, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K821492 · Instrumentation Industries, Inc. · Anesthesiology device
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Sep 1982
Decision
129d
Days
Class 2
Risk

K821492 is an FDA 510(k) clearance for the BE#6006 VAR. RESIS. INSPIR. MUSCLE. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1982 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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 Instrumentation Industries, Inc. devices

Submission Details

510(k) Number K821492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date September 24, 1982
Days to Decision 129 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
11d faster than avg
Panel avg: 140d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 - BWF Spirometer, Therapeutic (incentive)

All 27
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K821492.
VOFLEX
K840239 · Dhd Medical Products Div. Diemolding Corp. · Mar 1984
VOLUREX II
K833337 · Dhd Medical Products Div. Diemolding Corp. · Nov 1983
INSPIRATORY RESISTOR KIT
K831142 · Dhd Medical Products Div. Diemolding Corp. · Jun 1983
ARGYLE TRU-VOL
K800386 · Sherwood Medical Co. · Feb 1980
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214 · Starkey Laboratories, Inc. · Nov 1979
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · Airlife, Inc. · Nov 1979