Cleared Traditional

K790744 - LUNG FUNCTION AMPLIFIER EXERCISER

K790744 is an FDA 510(k) clearance for LUNG FUNCTION AMPLIFIER EXERCISER, manufactured by Empire Plastics Manufacturer. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K790744 · Empire Plastics Manufacturer · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
11d
Days
Class 2
Risk

K790744 is an FDA 510(k) clearance for the LUNG FUNCTION AMPLIFIER EXERCISER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Empire Plastics Manufacturer (Mchenry, US). The FDA issued a Cleared decision on April 27, 1979 after a review of 11 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.

View all Empire Plastics Manufacturer devices

FDA 510(k) Submission Details - K790744

510(k) Number K790744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1979
Decision Date April 27, 1979
Days to Decision 11 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K790744.
MOTIVATOR
K791842 · Puritan Bennett Corp. · Oct 1979
AIR INCENTIVE SPIROMETER
K791819 · Airlife, Inc. · Sep 1979
VOLUREX TM
K791015 · Dhd Medical Products Div. Diemolding Corp. · Jun 1979
SPIROMETER, INCENTIVE CATALOG # 1750
K781831 · Hudson Oxygen Therapy Sales Co. · Dec 1978
SPIROCARE 108-B
K782016 · Marion Laboratories, Inc. · Dec 1978
INCENT-O-NEB
K781731 · B & F Medical Products, Inc. · Dec 1978