Cleared Traditional

K771532 - SPIROMETEO & LUNG EXERCISER

K771532 is the FDA 510(k) clearance for SPIROMETEO & LUNG EXERCISER by Boehringer Laboratories. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771532 · Boehringer Laboratories · Anesthesiology device
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Aug 1977
Decision
16d
Days
Class 2
Risk

K771532 is an FDA 510(k) clearance for the SPIROMETEO & LUNG EXERCISER, 4601. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 26, 1977 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K771532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1977
Decision Date August 26, 1977
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
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.