510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K944344Substantially Equivalent

Lung Technologies 5000 Therapeutic Incentive Spirometer

Lung Technologies, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944344 is the FDA 510(k) clearance record for LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER, a class II device, cleared for Lung Technologies, Inc. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list one 510(k) clearance for Lung Technologies, Inc. As of , FDA records show no recalls naming K944344.

Clearance record

Decision date
Received
(150 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Lung Technologies, Inc. 2620 186th Ave. NE, Redmond WA
510(k) summary
Statement
Third party review
No

Clearances, product code BWF

Trailing 12 months

FDA records hold no clearances under product code BWF in the trailing twelve months.

FDA records show no clearances under product code BWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260