Cleared Traditional

K861564 - THE LUNG GYM (XLATOR AND NLATOR)

K861564 is the FDA 510(k) clearance for THE LUNG GYM (XLATOR AND NLATOR) by El-Fax Company, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K861564 · El-Fax Company, Inc. · Anesthesiology device
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Aug 1986
Decision
104d
Days
Class 2
Risk

K861564 is an FDA 510(k) clearance for the THE LUNG GYM (XLATOR AND NLATOR). Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by El-Fax Company, Inc. (Ardmore, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 104 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 El-Fax Company, Inc. devices

Submission Details

510(k) Number K861564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1986
Decision Date August 07, 1986
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
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 18
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K861564.
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