510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K946039Substantially Equivalent

Model #5000 Pulmo Plus

International Medical Systems, West Des Molnes IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946039 is the FDA 510(k) clearance record for MODEL #5000 PULMO PLUS, a class II device, cleared for International Medical Systems on under FDA product code BTI (Compressor, Air, Portable). FDA records list 2 510(k) clearances for International Medical Systems, from to . As of , FDA records show no recalls naming K946039.

Clearance record

Decision date
Received
(186 days to decision)
Product code
BTI Compressor, Air, Portable
Regulation
21 CFR 868.6250
Device class
Class II
Review panel
Anesthesiology
Applicant
International Medical Systems P.O. Box 66007, West Des Molnes IA
510(k) summary
Summary
Third party review
No

Clearances, product code BTI

Trailing 12 months

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

FDA records show no clearances under product code BTI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTI, 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