Cleared Traditional

K792217 - AIR INCENTIVE SPIROMETER

K792217 is the FDA 510(k) clearance for AIR INCENTIVE SPIROMETER by Airlife, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K792217 · Airlife, Inc. · Anesthesiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Nov 1979

Decision

22d

Days

Class 2

Risk

K792217 is an FDA 510(k) clearance for the AIR INCENTIVE SPIROMETER, W/NEBULIZER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 22 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 Airlife, Inc. devices

Submission Details

510(k) Number	K792217 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1979
Decision Date	November 27, 1979
Days to Decision	22 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

118d faster than avg

Panel avg: 140d · This submission: 22d

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 17

Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K792217.

VersaPAP Positive Airway Pressure (PAP) Device

K173918 · Trudell Medical International · Aug 2018

VITAL PEP

K984468 · Vital Signs, Inc. · Jun 1999

ARGYLE TRU-VOL

K800386 · Sherwood Medical Co. · Feb 1980

MOTIVATOR

K791842 · Puritan Bennett Corp. · Oct 1979

AIR INCENTIVE SPIROMETER

K791819 · Airlife, Inc. · Sep 1979

CALCULATOR, WITH CHARGER

K781838 · C.R. Bard, Inc. · Nov 1978

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K792217

Airlife, Inc.

Mchenry, IL · US

Regulatory profile

76 submissions 76 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active